Fecal Microbiota Transplantation in Females With Anorexia Nervosa

NCT07877675 | Not Yet Recruiting

• 2 other identifiers: H-260457295336-00067B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn whether fecal microbiota transplantation (FMT) can change the gut microbiome and improve health outcomes in females with anorexia nervosa. FMT involves transferring microorganisms from the stool of a carefully screened healthy donor to the intestine of another person. In this study, FMT will be given as capsules that are swallowed by the participants. The main questions the study aims to answer are:

• Does repeated treatment with FMT change the gut microbiome in females with anorexia nervosa?
• Does FMT improve symptoms and other health outcomes related to anorexia nervosa?
• How does FMT affect gastrointestinal function, including bowel habits and gut transit time in females with anorexia nervosa?
• What medical problems or side effects do the participants experience during the study? Researchers will compare FMT capsules with placebo capsules to see whether FMT affects the gut microbiome, gastrointestinal function, and symptoms related to anorexia nervosa. Placebo capsules are similar to the FMT capsules but do not contain donor fecal material. Participants will:
• Receive five weekly FMT treatments and five weekly placebo treatments
• Be randomly assigned to receive either FMT followed by placebo or placebo followed by FMT
• Attend four study visits for clinical assessments and follow-up
• Provide stool and blood samples at the study visits
• Complete questionnaires about eating disorder symptoms, gastrointestinal symptoms, and general health
• Provide information about bowel habits and other aspects of gastrointestinal function Neither the participants nor the study staff will know which treatment is being given during each treatment period. The study will include females aged 15 years or older with anorexia nervosa. The study will help researchers better understand the relationship between the gut microbiome and anorexia nervosa and whether changing the gut microbiome with FMT could potentially be a future treatment approach.

Conditions

Anorexia Nervosa

Keywords

Anorexia nervosa; Fecal microbiota transplantation; FMT; Gut microbiome; Gut microbiota; Microbiome; Eating disorders; Gastrointestinal function; Oral FMT; Placebo-controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Gut Microbiome Composition (T0-T1)

  The primary endpoint is defined as the change in GM composition from baseline (T0) to week 5 (T1), comparing participants randomized to receive FMT during the first treatment period with those randomized to receive placebo during the first treatment period. Microbiome compositions will be assessed using shotgun metagenomic sequencing of stool samples collected at T0 and T1. Global microbiome restructuring will be quantified using pre-specified compositional distance metrics based on centered log-ratio (CLR) transformed abundance data (e.g., Aitchison distance). In addition, the recipient microbiome distance to the assigned donor microbiome will be calculated to quantify movement toward donor composition following treatment. The primary analysis will estimate the difference between-group in microbiome compositional change and donor-recipient distance reduction during the first 5-week treatment period.

  Baseline (T0) - After first 5 weeks (T1)

Secondary Outcomes (3)

• Gut-/appetite-related clinical effects (T0-T1)

  Baseline (T0) - After first 5 weeks (T1)

• Eating-disorder symptom severity (T0-T1)

  Baseline (T0) - After first 5 weeks (T1)

• Change in eating-disorder symptom severity from baseline (T0) to the 3-month follow-up (T3)

  From baseline (T0) to to the 3-month follow-up (T3)

Study Arms (2)

A

EXPERIMENTAL

FMT week 1-5 → placebo week 6-10

Biological: Fecal Microbiota Transplantation Capsule; Other: Placebo Capsule(s)

B

EXPERIMENTAL

Placebo week 1-5 → FMT week 6-10

Biological: Fecal Microbiota Transplantation Capsule; Other: Placebo Capsule(s)

Interventions

Fecal Microbiota Transplantation Capsule BIOLOGICAL

Fecal microbiota transplantation (FMT) will be administered orally as capsules containing fecal material from carefully screened healthy donors. Participants will receive five weekly FMT treatments during the FMT treatment period. The FMT capsules will be prepared according to the study protocol and administered under the supervision of the study team.

A; B

Placebo Capsule(s) OTHER

Placebo capsules (low calorie) are made from saline containing 5% (v/v) glycerol, cornstarch and food coloring (food coloring E150).

A; B

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex.
• Age ≥15 years.
• Diagnosis of AN according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) which includes BMI\<18.5 or equivalent in adolescents.
• Ability to read and speak Danish.
• Ability to swallow study capsules.
• Provision of voluntary written informed consent prior to any study-specific procedures (and, for participants aged 15-17 years, written parental/legal guardian consent and participant assent in accordance with Danish regulations).
• Must have access to a standalone household freezer (Not in the freezer compartment of a refrigerator).

You may not qualify if:

• Age \<15 years.
• Male sex.
• Current use of laxatives.
• Any somatic comorbidity that requires current medical treatment.
• Systemic antibiotic treatment within the past 3 months.
• Known inflammatory bowel disease, colorectal cancer, or other clinically significant chronic gastrointestinal disorder.
• Pregnancy or breastfeeding.
• Current alcohol or substance use disorder.
• Known food allergy to E133 and E150c.

Sponsors & Collaborators

• Andreas Munk Petersen: lead
• Psychiatric Center Ballerup: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

Center for Eating and feeding Disorders Research (CEDaR), Specialist center for Eating Disorders for the Capital Region

Ballerup Municipality, Capital Region of Copenhagen, 2750, Denmark

Location

Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, Capital Region of Copenhagen, 2650, Denmark

Location

Related Publications (61)

• Satokari R, Mattila E, Kainulainen V, Arkkila PE. Simple faecal preparation and efficacy of frozen inoculum in faecal microbiota transplantation for recurrent Clostridium difficile infection--an observational cohort study. Aliment Pharmacol Ther. 2015 Jan;41(1):46-53. doi: 10.1111/apt.13009. Epub 2014 Oct 29.

  PMID: 25355279 BACKGROUND

• Hsu M, Tun KM, Batra K, Haque L, Vongsavath T, Hong AS. Safety and Efficacy of Fecal Microbiota Transplantation in Treatment of Inflammatory Bowel Disease in the Pediatric Population: A Systematic Review and Meta-Analysis. Microorganisms. 2023 May 12;11(5):1272. doi: 10.3390/microorganisms11051272.

  PMID: 37317246 BACKGROUND

• Rapoport EA, Baig M, Puli SR. Adverse events in fecal microbiota transplantation: a systematic review and meta-analysis. Ann Gastroenterol. 2022 Mar-Apr;35(2):150-163. doi: 10.20524/aog.2022.0695. Epub 2022 Feb 14.

  PMID: 35479587 BACKGROUND

• Karimi M, Shirsalimi N, Hashempour Z, Salehi Omran H, Sedighi E, Beigi F, Mortezazadeh M. Safety and efficacy of fecal microbiota transplantation (FMT) as a modern adjuvant therapy in various diseases and disorders: a comprehensive literature review. Front Immunol. 2024 Sep 26;15:1439176. doi: 10.3389/fimmu.2024.1439176. eCollection 2024.

  PMID: 39391303 BACKGROUND

• Diener C, Holscher HD, Filek K, Corbin KD, Moissl-Eichinger C, Gibbons SM. Metagenomic estimation of dietary intake from human stool. Nat Metab. 2025 Mar;7(3):617-630. doi: 10.1038/s42255-025-01220-1. Epub 2025 Feb 18.

  PMID: 39966520 BACKGROUND

• Amchova P, Siska F, Ruda-Kucerova J. Food Safety and Health Concerns of Synthetic Food Colors: An Update. Toxics. 2024 Jun 27;12(7):466. doi: 10.3390/toxics12070466.

  PMID: 39058118 BACKGROUND

• Asnicar F, Leeming ER, Dimidi E, Mazidi M, Franks PW, Al Khatib H, Valdes AM, Davies R, Bakker E, Francis L, Chan A, Gibson R, Hadjigeorgiou G, Wolf J, Spector TD, Segata N, Berry SE. Blue poo: impact of gut transit time on the gut microbiome using a novel marker. Gut. 2021 Sep;70(9):1665-1674. doi: 10.1136/gutjnl-2020-323877. Epub 2021 Mar 15.

  PMID: 33722860 BACKGROUND

• Chehri M, Christensen AH, Halkjaer SI, Gunther S, Petersen AM, Helms M. Case series of successful treatment with fecal microbiota transplant (FMT) oral capsules mixed from multiple donors even in patients previously treated with FMT enemas for recurrent Clostridium difficile infection. Medicine (Baltimore). 2018 Aug;97(31):e11706. doi: 10.1097/MD.0000000000011706.

  PMID: 30075573 BACKGROUND

• Cold F, Browne PD, Gunther S, Halkjaer SI, Petersen AM, Al-Gibouri Z, Hansen LH, Christensen AH. Multidonor FMT capsules improve symptoms and decrease fecal calprotectin in ulcerative colitis patients while treated - an open-label pilot study. Scand J Gastroenterol. 2019 Mar;54(3):289-296. doi: 10.1080/00365521.2019.1585939. Epub 2019 Apr 4.

  PMID: 30946615 BACKGROUND

• Halkjaer SI, Christensen AH, Lo BZS, Browne PD, Gunther S, Hansen LH, Petersen AM. Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study. Gut. 2018 Dec;67(12):2107-2115. doi: 10.1136/gutjnl-2018-316434. Epub 2018 Jul 6.

  PMID: 29980607 BACKGROUND

• Cold F, Svensson CK, Christensen AH, Gunther S, Petersen AM, Hansen LH, Helms M. Successful treatment of Clostridioidesdifficile infection with single-donorfaecal microbiota transplantation capsules. Dan Med J. 2022 Jan 20;69(2):A09210712.

  PMID: 35088703 BACKGROUND

• Knowles KA, Olatunji BO. Specificity of trait anxiety in anxiety and depression: Meta-analysis of the State-Trait Anxiety Inventory. Clin Psychol Rev. 2020 Dec;82:101928. doi: 10.1016/j.cpr.2020.101928. Epub 2020 Oct 10.

  PMID: 33091745 BACKGROUND

• Bech P, Rasmussen NA, Olsen LR, Noerholm V, Abildgaard W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord. 2001 Oct;66(2-3):159-64. doi: 10.1016/s0165-0327(00)00309-8.

  PMID: 11578668 BACKGROUND

• Fairburn CG, Beglin SJ. Assessment of eating disorders: interview or self-report questionnaire? Int J Eat Disord. 1994 Dec;16(4):363-70.

  PMID: 7866415 BACKGROUND

• Adair CE, Marcoux GC, Cram BS, Ewashen CJ, Chafe J, Cassin SE, Pinzon J, Gusella JL, Geller J, Scattolon Y, Fergusson P, Styles L, Brown KE. Development and multi-site validation of a new condition-specific quality of life measure for eating disorders. Health Qual Life Outcomes. 2007 Apr 30;5:23. doi: 10.1186/1477-7525-5-23.

  PMID: 17470290 BACKGROUND

• Baunwall SMD, Dahlerup JF, Engberg JH, Erikstrup C, Helms M, Juel MA, Kjeldsen J, Nielsen HL, Nilsson AC, Rode AA, Vinter-Jensen L, Hvas CL. Danish national guideline for the treatment of Clostridioides difficile infection and use of faecal microbiota transplantation (FMT). Scand J Gastroenterol. 2021 Sep;56(9):1056-1077. doi: 10.1080/00365521.2021.1922749. Epub 2021 Jul 14.

  PMID: 34261379 BACKGROUND

• Korpela K, Helve O, Kolho KL, Saisto T, Skogberg K, Dikareva E, Stefanovic V, Salonen A, Andersson S, de Vos WM. Maternal Fecal Microbiota Transplantation in Cesarean-Born Infants Rapidly Restores Normal Gut Microbial Development: A Proof-of-Concept Study. Cell. 2020 Oct 15;183(2):324-334.e5. doi: 10.1016/j.cell.2020.08.047. Epub 2020 Oct 1.

  PMID: 33007265 BACKGROUND

• Mashiah J, Karady T, Fliss-Isakov N, Sprecher E, Slodownik D, Artzi O, Samuelov L, Ellenbogen E, Godneva A, Segal E, Maharshak N. Clinical efficacy of fecal microbial transplantation treatment in adults with moderate-to-severe atopic dermatitis. Immun Inflamm Dis. 2022 Mar;10(3):e570. doi: 10.1002/iid3.570. Epub 2021 Dec 20.

  PMID: 34931478 BACKGROUND

• Khoruts A, Staley C, Sadowsky MJ. Faecal microbiota transplantation for Clostridioides difficile: mechanisms and pharmacology. Nat Rev Gastroenterol Hepatol. 2021 Jan;18(1):67-80. doi: 10.1038/s41575-020-0350-4. Epub 2020 Aug 25.

  PMID: 32843743 BACKGROUND

• Sha S, Liang J, Chen M, Xu B, Liang C, Wei N, Wu K. Systematic review: faecal microbiota transplantation therapy for digestive and nondigestive disorders in adults and children. Aliment Pharmacol Ther. 2014 May;39(10):1003-32. doi: 10.1111/apt.12699. Epub 2014 Mar 18.

  PMID: 24641570 BACKGROUND

• Cold F, Svensson CK, Petersen AM, Hansen LH, Helms M. Long-Term Safety Following Faecal Microbiota Transplantation as a Treatment for Recurrent Clostridioides difficile Infection Compared with Patients Treated with a Fixed Bacterial Mixture: Results from a Retrospective Cohort Study. Cells. 2022 Jan 27;11(3):435. doi: 10.3390/cells11030435.

  PMID: 35159245 BACKGROUND

• Gefen R, Dourado J, Emile SH, Wignakumar A, Rogers P, Aeschbacher P, Garoufalia Z, Horesh N, Wexner SD. Fecal microbiota transplantation for patients with ulcerative colitis: a systematic review and meta-analysis of randomized control trials. Tech Coloproctol. 2025 Apr 17;29(1):103. doi: 10.1007/s10151-025-03113-7.

  PMID: 40246750 BACKGROUND

• Zipursky JS, Sidorsky TI, Freedman CA, Sidorsky MN, Kirkland KB. Patient attitudes toward the use of fecal microbiota transplantation in the treatment of recurrent Clostridium difficile infection. Clin Infect Dis. 2012 Dec;55(12):1652-8. doi: 10.1093/cid/cis809. Epub 2012 Sep 18.

  PMID: 22990849 BACKGROUND

• Song YN, Yang DY, Veldhuyzen van Zanten S, Wong K, McArthur E, Song CZ, Ianiro G, Cammarota G, Kelly C, Fischer M, Russell L, Kao D. Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile Infection: Systematic Review and Meta-analysis. J Can Assoc Gastroenterol. 2021 Jul 23;5(1):e1-e11. doi: 10.1093/jcag/gwab023. eCollection 2022 Feb.

  PMID: 35118227 BACKGROUND

• Wilson BC, Tweedie-Cullen RY, Albert BB, Derraik JGB, Ho D, Depczynski M, Creagh C, Edwards T, Gali S, Thabrew H, Cutfield WS, O'Sullivan JM. Encapsulated faecal microbiota transfer in young women with anorexia nervosa: an open-label feasibility pilot trial. Nat Commun. 2025 Dec 14;17(1):571. doi: 10.1038/s41467-025-67267-6.

  PMID: 41392089 BACKGROUND

• Maschek S, Ostergaard TH, Krych L, Zachariassen LF, Sorensen DB, Junker Mentzel CM, Hansen AK, Sjogren JM, Barfod KK. Investigating fecal microbiota transplants from individuals with anorexia nervosa in antibiotic-treated mice using a cross-over study design. J Eat Disord. 2025 May 13;13(1):82. doi: 10.1186/s40337-025-01276-0.

  PMID: 40361238 BACKGROUND

• Gabriel-Segard T, Heberden C, Mondot S, Duquesnoy M, Dicembre M, Naudon L, Philippe C, Maximin E, Blais A, Jacota M, Lapaque N, Blottiere HM, Paul S, Dore J, Rabot S, Hanachi M. Anorexia nervosa symptoms are induced after specific gut microbiota dysbiosis transfer in germ-free mice. Gut Microbes. 2025 Dec 31;17(1):2563701. doi: 10.1080/19490976.2025.2563701. Epub 2025 Nov 15.

  PMID: 41239983 BACKGROUND

• Fan Y, Stoving RK, Berreira Ibraim S, Hyotylainen T, Thirion F, Arora T, Lyu L, Stankevic E, Hansen TH, Dechelotte P, Sinioja T, Ragnarsdottir O, Pons N, Galleron N, Quinquis B, Levenez F, Roume H, Falony G, Vieira-Silva S, Raes J, Clausen L, Telleus GK, Backhed F, Oresic M, Ehrlich SD, Pedersen O. The gut microbiota contributes to the pathogenesis of anorexia nervosa in humans and mice. Nat Microbiol. 2023 May;8(5):787-802. doi: 10.1038/s41564-023-01355-5. Epub 2023 Apr 17.

  PMID: 37069399 BACKGROUND

• Glenny EM, Fouladi F, Thomas SA, Bulik-Sullivan EC, Tang Q, Djukic Z, Trillo-Ordonez YS, A Fodor A, Tarantino LM, M Bulik C, M Carroll I. Gut microbial communities from patients with anorexia nervosa do not influence body weight in recipient germ-free mice. Gut Microbes. 2021 Jan-Dec;13(1):1-15. doi: 10.1080/19490976.2021.1897216.

  PMID: 33769200 BACKGROUND

• Hata T, Miyata N, Takakura S, Yoshihara K, Asano Y, Kimura-Todani T, Yamashita M, Zhang XT, Watanabe N, Mikami K, Koga Y, Sudo N. The Gut Microbiome Derived From Anorexia Nervosa Patients Impairs Weight Gain and Behavioral Performance in Female Mice. Endocrinology. 2019 Oct 1;160(10):2441-2452. doi: 10.1210/en.2019-00408.

  PMID: 31504398 BACKGROUND

• Mack I, Cuntz U, Gramer C, Niedermaier S, Pohl C, Schwiertz A, Zimmermann K, Zipfel S, Enck P, Penders J. Weight gain in anorexia nervosa does not ameliorate the faecal microbiota, branched chain fatty acid profiles, and gastrointestinal complaints. Sci Rep. 2016 May 27;6:26752. doi: 10.1038/srep26752.

  PMID: 27229737 BACKGROUND

• Tomasova P, Prochazkova P, Roubalova R, Dvorak J, Tlaskalova-Hogenova H, Cermakova M, Pelantova H, Sediva B, Vecka M, Papezova H, Kuzma M. NMR- and MS-Based Untargeted Metabolomic Study of Stool and Serum Samples from Patients with Anorexia Nervosa. J Proteome Res. 2022 Mar 4;21(3):778-787. doi: 10.1021/acs.jproteome.1c00537. Epub 2021 Oct 4.

  PMID: 34606283 BACKGROUND

• Kleiman SC, Glenny EM, Bulik-Sullivan EC, Huh EY, Tsilimigras MCB, Fodor AA, Bulik CM, Carroll IM. Daily Changes in Composition and Diversity of the Intestinal Microbiota in Patients with Anorexia Nervosa: A Series of Three Cases. Eur Eat Disord Rev. 2017 Sep;25(5):423-427. doi: 10.1002/erv.2524. Epub 2017 Jun 6.

  PMID: 28586130 BACKGROUND

• Morkl S, Lackner S, Muller W, Gorkiewicz G, Kashofer K, Oberascher A, Painold A, Holl A, Holzer P, Meinitzer A, Mangge H, Holasek S. Gut microbiota and body composition in anorexia nervosa inpatients in comparison to athletes, overweight, obese, and normal weight controls. Int J Eat Disord. 2017 Dec;50(12):1421-1431. doi: 10.1002/eat.22801. Epub 2017 Nov 13.

  PMID: 29131365 BACKGROUND

• Monteleone AM, Troisi J, Fasano A, Dalle Grave R, Marciello F, Serena G, Calugi S, Scala G, Corrivetti G, Cascino G, Monteleone P, Maj M. Multi-omics data integration in anorexia nervosa patients before and after weight regain: A microbiome-metabolomics investigation. Clin Nutr. 2021 Mar;40(3):1137-1146. doi: 10.1016/j.clnu.2020.07.021. Epub 2020 Jul 31.

  PMID: 32782162 BACKGROUND

• Prochazkova P, Roubalova R, Dvorak J, Kreisinger J, Hill M, Tlaskalova-Hogenova H, Tomasova P, Pelantova H, Cermakova M, Kuzma M, Bulant J, Bilej M, Smitka K, Lambertova A, Holanova P, Papezova H. The intestinal microbiota and metabolites in patients with anorexia nervosa. Gut Microbes. 2021 Jan-Dec;13(1):1-25. doi: 10.1080/19490976.2021.1902771.

  PMID: 33779487 BACKGROUND

• Morita C, Tsuji H, Hata T, Gondo M, Takakura S, Kawai K, Yoshihara K, Ogata K, Nomoto K, Miyazaki K, Sudo N. Gut Dysbiosis in Patients with Anorexia Nervosa. PLoS One. 2015 Dec 18;10(12):e0145274. doi: 10.1371/journal.pone.0145274. eCollection 2015.

  PMID: 26682545 BACKGROUND

• Levy M, Kolodziejczyk AA, Thaiss CA, Elinav E. Dysbiosis and the immune system. Nat Rev Immunol. 2017 Apr;17(4):219-232. doi: 10.1038/nri.2017.7. Epub 2017 Mar 6.

  PMID: 28260787 BACKGROUND

• Liang D, Leung RK, Guan W, Au WW. Involvement of gut microbiome in human health and disease: brief overview, knowledge gaps and research opportunities. Gut Pathog. 2018 Jan 25;10:3. doi: 10.1186/s13099-018-0230-4. eCollection 2018.

  PMID: 29416567 BACKGROUND

• Roubalova R, Prochazkova P, Papezova H, Smitka K, Bilej M, Tlaskalova-Hogenova H. Anorexia nervosa: Gut microbiota-immune-brain interactions. Clin Nutr. 2020 Mar;39(3):676-684. doi: 10.1016/j.clnu.2019.03.023. Epub 2019 Mar 23.

  PMID: 30952533 BACKGROUND

• Carabotti M, Scirocco A, Maselli MA, Severi C. The gut-brain axis: interactions between enteric microbiota, central and enteric nervous systems. Ann Gastroenterol. 2015 Apr-Jun;28(2):203-209.

  PMID: 25830558 BACKGROUND

• Dalile B, Van Oudenhove L, Vervliet B, Verbeke K. The role of short-chain fatty acids in microbiota-gut-brain communication. Nat Rev Gastroenterol Hepatol. 2019 Aug;16(8):461-478. doi: 10.1038/s41575-019-0157-3.

  PMID: 31123355 BACKGROUND

• Nicholson JK, Holmes E, Kinross J, Burcelin R, Gibson G, Jia W, Pettersson S. Host-gut microbiota metabolic interactions. Science. 2012 Jun 8;336(6086):1262-7. doi: 10.1126/science.1223813. Epub 2012 Jun 6.

  PMID: 22674330 BACKGROUND

• Neuman H, Debelius JW, Knight R, Koren O. Microbial endocrinology: the interplay between the microbiota and the endocrine system. FEMS Microbiol Rev. 2015 Jul;39(4):509-21. doi: 10.1093/femsre/fuu010. Epub 2015 Feb 19.

  PMID: 25701044 BACKGROUND

• Cryan JF, O'Mahony SM. The microbiome-gut-brain axis: from bowel to behavior. Neurogastroenterol Motil. 2011 Mar;23(3):187-92. doi: 10.1111/j.1365-2982.2010.01664.x.

  PMID: 21303428 BACKGROUND

• Sekirov I, Russell SL, Antunes LC, Finlay BB. Gut microbiota in health and disease. Physiol Rev. 2010 Jul;90(3):859-904. doi: 10.1152/physrev.00045.2009.

  PMID: 20664075 BACKGROUND

• Hand TW, Vujkovic-Cvijin I, Ridaura VK, Belkaid Y. Linking the Microbiota, Chronic Disease, and the Immune System. Trends Endocrinol Metab. 2016 Dec;27(12):831-843. doi: 10.1016/j.tem.2016.08.003. Epub 2016 Sep 10.

  PMID: 27623245 BACKGROUND

• Backhed F, Ley RE, Sonnenburg JL, Peterson DA, Gordon JI. Host-bacterial mutualism in the human intestine. Science. 2005 Mar 25;307(5717):1915-20. doi: 10.1126/science.1104816.

  PMID: 15790844 BACKGROUND

• Bailer UF, Frank GK, Price JC, Meltzer CC, Becker C, Mathis CA, Wagner A, Barbarich-Marsteller NC, Bloss CS, Putnam K, Schork NJ, Gamst A, Kaye WH. Interaction between serotonin transporter and dopamine D2/D3 receptor radioligand measures is associated with harm avoidant symptoms in anorexia and bulimia nervosa. Psychiatry Res. 2013 Feb 28;211(2):160-8. doi: 10.1016/j.pscychresns.2012.06.010. Epub 2012 Nov 13.

  PMID: 23154100 BACKGROUND

• Stoving RK. MECHANISMS IN ENDOCRINOLOGY: Anorexia nervosa and endocrinology: a clinical update. Eur J Endocrinol. 2019 Jan 1;180(1):R9-R27. doi: 10.1530/EJE-18-0596.

  PMID: 30400050 BACKGROUND

• Hinney A, Volckmar AL. Genetics of eating disorders. Curr Psychiatry Rep. 2013 Dec;15(12):423. doi: 10.1007/s11920-013-0423-y.

  PMID: 24202964 BACKGROUND

• Gorwood P, Kipman A, Foulon C. The human genetics of anorexia nervosa. Eur J Pharmacol. 2003 Nov 7;480(1-3):163-70. doi: 10.1016/j.ejphar.2003.08.103.

  PMID: 14623359 BACKGROUND

• Moskowitz L, Weiselberg E. Anorexia Nervosa/Atypical Anorexia Nervosa. Curr Probl Pediatr Adolesc Health Care. 2017 Apr;47(4):70-84. doi: 10.1016/j.cppeds.2017.02.003.

  PMID: 28532965 BACKGROUND

• Zipfel S, Sammet I, Rapps N, Herzog W, Herpertz S, Martens U. Gastrointestinal disturbances in eating disorders: clinical and neurobiological aspects. Auton Neurosci. 2006 Oct 30;129(1-2):99-106. doi: 10.1016/j.autneu.2006.07.023. Epub 2006 Sep 7.

  PMID: 16962383 BACKGROUND

• Riedlinger C, Schmidt G, Weiland A, Stengel A, Giel KE, Zipfel S, Enck P, Mack I. Which Symptoms, Complaints and Complications of the Gastrointestinal Tract Occur in Patients With Eating Disorders? A Systematic Review and Quantitative Analysis. Front Psychiatry. 2020 Apr 20;11:195. doi: 10.3389/fpsyt.2020.00195. eCollection 2020.

  PMID: 32425816 BACKGROUND

• Bulik CM, Carroll IM, Mehler P. Reframing anorexia nervosa as a metabo-psychiatric disorder. Trends Endocrinol Metab. 2021 Oct;32(10):752-761. doi: 10.1016/j.tem.2021.07.010. Epub 2021 Aug 20.

  PMID: 34426039 BACKGROUND

• Steinhausen HC. The outcome of anorexia nervosa in the 20th century. Am J Psychiatry. 2002 Aug;159(8):1284-93. doi: 10.1176/appi.ajp.159.8.1284.

  PMID: 12153817 BACKGROUND

• Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.

  PMID: 21727255 BACKGROUND

• Winkler LA, Christiansen E, Lichtenstein MB, Hansen NB, Bilenberg N, Stoving RK. Quality of life in eating disorders: a meta-analysis. Psychiatry Res. 2014 Sep 30;219(1):1-9. doi: 10.1016/j.psychres.2014.05.002. Epub 2014 May 14.

  PMID: 24857566 BACKGROUND

• Watson HJ, Bulik CM. Update on the treatment of anorexia nervosa: review of clinical trials, practice guidelines and emerging interventions. Psychol Med. 2013 Dec;43(12):2477-500. doi: 10.1017/S0033291712002620. Epub 2012 Dec 10.

  PMID: 23217606 BACKGROUND

• Treasure J, Duarte TA, Schmidt U. Eating disorders. Lancet. 2020 Mar 14;395(10227):899-911. doi: 10.1016/S0140-6736(20)30059-3.

  PMID: 32171414 BACKGROUND

MeSH Terms

Conditions

Anorexia Nervosa; Feeding and Eating Disorders

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Andreas Munk Petersen, Professor, MD, PhD, DMSc

  Gastrounit, Medical Section and Department of Clinical Microbiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark, and Department of Clinical Medicine, University of Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

• Kenneth Klingenberg Barfod, Associate Professor, MSc, PhD

  Food Microbiology, Gut Health and Fermentation, Department of Food Science (FOOD), University of Copenhagen, Denmark

  STUDY DIRECTOR

• Nadia Micali, Professor, MD, MRCPsych, PhD

  Center for Eating and feeding Disorders Research (CEDaR), Specialist center for Eating Disorders for the Capital Region , Copenhagen University Hospital Herlev and Gentofte Hospital, Denmark

  STUDY CHAIR

• Morten Helms, MD, PhD

  Department of Infectious Diseases, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

  STUDY DIRECTOR

• Sofie Ingdam Halkjær, MSc, PhD

  Gastrounit, Medical Section, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

  STUDY CHAIR

• Hengameh Chloé Lauridsen, MSc-Eng, PhD

  Department of Infectious Diseases, Copenhagen University Hospital Amger and Hvidovre, Hvidovre, Denmark

  STUDY DIRECTOR

• Dennis Sandris Nielsen, Professor, MSc, PhD

  Food Microbiology, Gut Health and Fermentation, Department of Food Science (FOOD), University of Copenhagen, Denmark

  STUDY CHAIR

• René Klinkby Støving, Professor, MD, PhD

  Department of Endocrinology, Center for Eating Disorders, Odense University Hospital, Denmark

  STUDY CHAIR

• Dorte Bonde Zilstorff, MD

  Gastrounit, Medical Section and Department of Clinical Microbiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark

  STUDY DIRECTOR

• Ingrid Maria Cecilia Rubin, Associate professor, MD, PhD

  Gastrounit, Medical Section and Department of Clinical Microbiology, Copenhagen University Hospital - Amager and Hvidovre, Hvidovre, Denmark, and Department of Clinical Medicine, University of Copenhagen, Denmark

  STUDY CHAIR

• Stefana Darvariu, MSc

  Center for Eating and feeding Disorders Research (CEDaR), Specialist center for Eating Disorders for the Capital Region, Copenhagen University Hospital Herlev and Gentofte Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Kenneth Klingenberg Barfod, Associate Professor, MSc, PhD

CONTACT

004535325208; kenneth.barfod@food.ku.dk

Dorte Bonde Zilstorff, MD

CONTACT

dorte.bonde.zilstorff@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD, DMSc

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 16, 2026
• Study Start (Estimated): November 16, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 16, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)