Multi-omics Dissection of Gut Microbiome Engraftment During FMT

NCT06992453 | Not Yet Recruiting

• 1 other identifier: 7416
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The gut microbiota plays a key role in immunity and metabolism and contributes to diseases such as recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). Microbiota therapeutics, particularly fecal microbiota transplantation (FMT), show promise-achieving \~90% cure rates in rCDI-but demonstrate variable efficacy in chronic conditions. Microbiome engraftment appears critical for FMT success, yet consistent predictors remain lacking. A meta-analysis of 20 FMT studies by our group and the Segata Lab linked engraftment to clinical response across diseases, with taxon-specific patterns and ML-based predictability. While viral, fungal, host immune, genetic, and metabolic factors may affect engraftment, their roles are not well-defined. Key unresolved questions include the interplay among host factors, microbial strains, and metabolites, their influence on engraftment, and impact on clinical outcomes. This study aims to unravel microbiome engraftment dynamics and link them to therapeutic response.

Conditions

Metabolic Syndrome (MetS); Recurrent C. Difficile (rCDI); Ulcerative Colitis (UC)

Keywords

Microbiome engraftment; Gut ecosystem; Fecal microbiota transplantation

Outcome Measures

Primary Outcomes (1)

• Longitudinal Analysis of Host-Microbiome Interactions Driving Microbial Engraftment

  To assess the longitudinal multidomain interactions of host and microbiome variables and their influence on microbial engraftment. Microbiome taxonomic profiling will be performed following the general guidelines and relying on the bioBakery computational environment. The taxonomic profiling and quantification of organisms' relative abundances of all metagenomic samples will be quantified using MetaPhlAn 3.0 (species-level profiling) and StrainPhlAn 3 (strain-level profiling). Metatranscriptomics (MTR), metabolomics (MTB) and metaproteomics (MTP) will be performed in stool samples. Through Multiplex Bead analysis for the assessment of specific cytokine in biopsy samples will be perform, following manufacturer's instructions. Flow cytometry will be also performed in colonic biopsies to identify the specific phenotype of immune cells localized in the mucosal samples.

  60 months

Secondary Outcomes (1)

• Longitudinal Analysis of Host-Microbiome Interactions and Their Impact on Clinical Outcomes

  60 months

Study Arms (3)

Recurrent C. difficile infection (rCDI) Cohort

EXPERIMENTAL

Patients with recurrent C. difficile infection (rCDI) will be recruited among those referred to the Digestive Disease Centre (CEMAD) of the Fondazione Policlinico Universitario A. Gemelli IRCCS. Patients with all inclusion criteria and none of the exclusion criteria will be considered for this study.

Other: Fecal microbiota transplantation (FMT)

Ulcerative Colitis (UC) Cohort

EXPERIMENTAL

Patients with Ulcerative Colitis (UC) will be recruited among those referred to the Digestive Disease Centre (CEMAD) of the Fondazione Policlinico Universitario A. Gemelli IRCCS. Patients with all inclusion criteria and none of the exclusion criteria will be considered for this study.

Other: Fecal microbiota transplantation (FMT)

Metabolic syndrome (MetS) Cohort

EXPERIMENTAL

Patients with metabolic syndrome (MetS), will be recruited among those referred to the Digestive Disease Centre (CEMAD) and to the Endocrine and Metabolic Diseases Unit of the Fondazione Policlinico Universitario A. Gemelli IRCCS.

Other: Fecal microbiota transplantation (FMT)

Interventions

Fecal microbiota transplantation (FMT) OTHER

Patients will receive a first donor FMT by colonoscopy, after a pre-conditioning with vancomycin and neomycin + bacitracin for 3 days, because data from our group show that pre-FMT antibiotics are associated with higher rates of microbial engraftment. Then they will receive two cycles, respectively after 3 and 7 days after colonoscopy - FMT, of frozen donor FMT capsules (15 capsules b.i.d. per 3 days). Patients will always receive feces from the same donor.

Metabolic syndrome (MetS) Cohort; Recurrent C. difficile infection (rCDI) Cohort; Ulcerative Colitis (UC) Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Coorte: Patients affected by Ulcerative Colitis
• Age ≥18 years.
• UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23)
• UC during stable maintenance therapy (\> 8 weeks with salicylates, immunosuppressants);
• Ability to give informed consent.
• Coorte: Patients affected by metabolic syndrome
• Age ≥18 years.
• Patients with MetS (high glycaemia levels (\> 100 mg/dL), hypertension (\> 130/85 mmHg), raised triglyceride levels (\> 150 mg/dL), low high-density lipoprotein cholesterol levels (\< 40 mg/dL in men; \<50 mg/dL in women), and abdominal obesity (waist circumference of \> 102 cm in men; \>88 cm in women)
• Stable treatment (\> 8 weeks) of one of these disorders, included in MetS definition.
• Ability to give informed consent
• Coorte: Patients affected by rCDI
• Age ≥18 years
• Mild recurrent Clostridioides difficile infection (26)
• Ability to give informed consent.

You may not qualify if:

• Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women).
• Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI)
• Previous colorectal surgery or cutaneous stoma
• Critical and severe comorbidities
• Inability to give informed consent.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Rome, RM, 00168, Italy

Location

Related Publications (45)

• D'Haens GR, Jobin C. Fecal Microbial Transplantation for Diseases Beyond Recurrent Clostridium Difficile Infection. Gastroenterology. 2019 Sep;157(3):624-636. doi: 10.1053/j.gastro.2019.04.053. Epub 2019 Jun 17.

  PMID: 31220424 RESULT

• Ianiro G, Bibbo S, Gasbarrini A, Cammarota G. Therapeutic modulation of gut microbiota: current clinical applications and future perspectives. Curr Drug Targets. 2014;15(8):762-70. doi: 10.2174/1389450115666140606111402.

  PMID: 24909808 RESULT

• Tixier EN, Verheyen E, Luo Y, Grinspan LT, Du CH, Ungaro RC, Walsh S, Grinspan AM. Systematic Review with Meta-Analysis: Fecal Microbiota Transplantation for Severe or Fulminant Clostridioides difficile. Dig Dis Sci. 2022 Mar;67(3):978-988. doi: 10.1007/s10620-021-06908-4. Epub 2021 Mar 22.

  PMID: 33748913 RESULT

• Baunwall SMD, Lee MM, Eriksen MK, Mullish BH, Marchesi JR, Dahlerup JF, Hvas CL. Faecal microbiota transplantation for recurrent Clostridioides difficile infection: An updated systematic review and meta-analysis. EClinicalMedicine. 2020 Nov 23;29-30:100642. doi: 10.1016/j.eclinm.2020.100642. eCollection 2020 Dec.

  PMID: 33437951 RESULT

• Ianiro G, Eusebi LH, Black CJ, Gasbarrini A, Cammarota G, Ford AC. Systematic review with meta-analysis: efficacy of faecal microbiota transplantation for the treatment of irritable bowel syndrome. Aliment Pharmacol Ther. 2019 Aug;50(3):240-248. doi: 10.1111/apt.15330. Epub 2019 May 28.

  PMID: 31136009 RESULT

• Costello SP, Soo W, Bryant RV, Jairath V, Hart AL, Andrews JM. Systematic review with meta-analysis: faecal microbiota transplantation for the induction of remission for active ulcerative colitis. Aliment Pharmacol Ther. 2017 Aug;46(3):213-224. doi: 10.1111/apt.14173. Epub 2017 Jun 14.

  PMID: 28612983 RESULT

• Proenca IM, Allegretti JR, Bernardo WM, de Moura DTH, Ponte Neto AM, Matsubayashi CO, Flor MM, Kotinda APST, de Moura EGH. Fecal microbiota transplantation improves metabolic syndrome parameters: systematic review with meta-analysis based on randomized clinical trials. Nutr Res. 2020 Nov;83:1-14. doi: 10.1016/j.nutres.2020.06.018. Epub 2020 Jul 3.

  PMID: 32987284 RESULT

• Ianiro G, Sanguinetti M, Gasbarrini A, Cammarota G. Predictors of failure after single faecal microbiota transplantation in patients with recurrent Clostridium difficile infection: results from a 3-year cohort study: authors' reply. Clin Microbiol Infect. 2017 Nov;23(11):891. doi: 10.1016/j.cmi.2017.05.005. Epub 2017 May 11. No abstract available.

  PMID: 28502839 RESULT

• Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.

  PMID: 25857665 RESULT

• Ianiro G, Maida M, Burisch J, Simonelli C, Hold G, Ventimiglia M, Gasbarrini A, Cammarota G. Efficacy of different faecal microbiota transplantation protocols for Clostridium difficile infection: A systematic review and meta-analysis. United European Gastroenterol J. 2018 Oct;6(8):1232-1244. doi: 10.1177/2050640618780762. Epub 2018 Jun 3.

  PMID: 30288286 RESULT

• Zuo T, Wong SH, Lam K, Lui R, Cheung K, Tang W, Ching JYL, Chan PKS, Chan MCW, Wu JCY, Chan FKL, Yu J, Sung JJY, Ng SC. Bacteriophage transfer during faecal microbiota transplantation in Clostridium difficile infection is associated with treatment outcome. Gut. 2018 Apr;67(4):634-643. doi: 10.1136/gutjnl-2017-313952. Epub 2017 May 24.

  PMID: 28539351 RESULT

• Zuo T, Wong SH, Cheung CP, Lam K, Lui R, Cheung K, Zhang F, Tang W, Ching JYL, Wu JCY, Chan PKS, Sung JJY, Yu J, Chan FKL, Ng SC. Gut fungal dysbiosis correlates with reduced efficacy of fecal microbiota transplantation in Clostridium difficile infection. Nat Commun. 2018 Sep 10;9(1):3663. doi: 10.1038/s41467-018-06103-6.

  PMID: 30202057 RESULT

• Kootte RS, Levin E, Salojarvi J, Smits LP, Hartstra AV, Udayappan SD, Hermes G, Bouter KE, Koopen AM, Holst JJ, Knop FK, Blaak EE, Zhao J, Smidt H, Harms AC, Hankemeijer T, Bergman JJGHM, Romijn HA, Schaap FG, Olde Damink SWM, Ackermans MT, Dallinga-Thie GM, Zoetendal E, de Vos WM, Serlie MJ, Stroes ESG, Groen AK, Nieuwdorp M. Improvement of Insulin Sensitivity after Lean Donor Feces in Metabolic Syndrome Is Driven by Baseline Intestinal Microbiota Composition. Cell Metab. 2017 Oct 3;26(4):611-619.e6. doi: 10.1016/j.cmet.2017.09.008.

  PMID: 28978426 RESULT

• Vaughn BP, Vatanen T, Allegretti JR, Bai A, Xavier RJ, Korzenik J, Gevers D, Ting A, Robson SC, Moss AC. Increased Intestinal Microbial Diversity Following Fecal Microbiota Transplant for Active Crohn's Disease. Inflamm Bowel Dis. 2016 Sep;22(9):2182-90. doi: 10.1097/MIB.0000000000000893.

  PMID: 27542133 RESULT

• Turpin W, Espin-Garcia O, Xu W, Silverberg MS, Kevans D, Smith MI, Guttman DS, Griffiths A, Panaccione R, Otley A, Xu L, Shestopaloff K, Moreno-Hagelsieb G; GEM Project Research Consortium; Paterson AD, Croitoru K. Association of host genome with intestinal microbial composition in a large healthy cohort. Nat Genet. 2016 Nov;48(11):1413-1417. doi: 10.1038/ng.3693. Epub 2016 Oct 3.

  PMID: 27694960 RESULT

• Goodrich JK, Davenport ER, Clark AG, Ley RE. The Relationship Between the Human Genome and Microbiome Comes into View. Annu Rev Genet. 2017 Nov 27;51:413-433. doi: 10.1146/annurev-genet-110711-155532. Epub 2017 Sep 20.

  PMID: 28934590 RESULT

• Danne C, Rolhion N, Sokol H. Recipient factors in faecal microbiota transplantation: one stool does not fit all. Nat Rev Gastroenterol Hepatol. 2021 Jul;18(7):503-513. doi: 10.1038/s41575-021-00441-5. Epub 2021 Apr 27.

  PMID: 33907321 RESULT

• Littmann ER, Lee JJ, Denny JE, Alam Z, Maslanka JR, Zarin I, Matsuda R, Carter RA, Susac B, Saffern MS, Fett B, Mattei LM, Bittinger K, Abt MC. Host immunity modulates the efficacy of microbiota transplantation for treatment of Clostridioides difficile infection. Nat Commun. 2021 Feb 2;12(1):755. doi: 10.1038/s41467-020-20793-x.

  PMID: 33531483 RESULT

• Lewis JD, Chuai S, Nessel L, Lichtenstein GR, Aberra FN, Ellenberg JH. Use of the noninvasive components of the Mayo score to assess clinical response in ulcerative colitis. Inflamm Bowel Dis. 2008 Dec;14(12):1660-6. doi: 10.1002/ibd.20520.

  PMID: 18623174 RESULT

• Lavelle A, Sokol H. Gut microbiota-derived metabolites as key actors in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2020 Apr;17(4):223-237. doi: 10.1038/s41575-019-0258-z. Epub 2020 Feb 19.

  PMID: 32076145 RESULT

• Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.

  PMID: 27329806 RESULT

• Zimmet P, Magliano D, Matsuzawa Y, Alberti G, Shaw J. The metabolic syndrome: a global public health problem and a new definition. J Atheroscler Thromb. 2005;12(6):295-300. doi: 10.5551/jat.12.295.

  PMID: 16394610 RESULT

• Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.

  PMID: 19805654 RESULT

• McDonald LC, Gerding DN, Johnson S, Bakken JS, Carroll KC, Coffin SE, Dubberke ER, Garey KW, Gould CV, Kelly C, Loo V, Shaklee Sammons J, Sandora TJ, Wilcox MH. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clin Infect Dis. 2018 Mar 19;66(7):987-994. doi: 10.1093/cid/ciy149.

  PMID: 29562266 RESULT

• Costello SP, Hughes PA, Waters O, Bryant RV, Vincent AD, Blatchford P, Katsikeros R, Makanyanga J, Campaniello MA, Mavrangelos C, Rosewarne CP, Bickley C, Peters C, Schoeman MN, Conlon MA, Roberts-Thomson IC, Andrews JM. Effect of Fecal Microbiota Transplantation on 8-Week Remission in Patients With Ulcerative Colitis: A Randomized Clinical Trial. JAMA. 2019 Jan 15;321(2):156-164. doi: 10.1001/jama.2018.20046.

  PMID: 30644982 RESULT

• Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.

  PMID: 10480510 RESULT

• Mari A, Pacini G, Murphy E, Ludvik B, Nolan JJ. A model-based method for assessing insulin sensitivity from the oral glucose tolerance test. Diabetes Care. 2001 Mar;24(3):539-48. doi: 10.2337/diacare.24.3.539.

  PMID: 11289482 RESULT

• Cammarota G, Masucci L, Ianiro G, Bibbo S, Dinoi G, Costamagna G, Sanguinetti M, Gasbarrini A. Randomised clinical trial: faecal microbiota transplantation by colonoscopy vs. vancomycin for the treatment of recurrent Clostridium difficile infection. Aliment Pharmacol Ther. 2015 May;41(9):835-43. doi: 10.1111/apt.13144. Epub 2015 Mar 1.

  PMID: 25728808 RESULT

• Baruch EN, Youngster I, Ben-Betzalel G, Ortenberg R, Lahat A, Katz L, Adler K, Dick-Necula D, Raskin S, Bloch N, Rotin D, Anafi L, Avivi C, Melnichenko J, Steinberg-Silman Y, Mamtani R, Harati H, Asher N, Shapira-Frommer R, Brosh-Nissimov T, Eshet Y, Ben-Simon S, Ziv O, Khan MAW, Amit M, Ajami NJ, Barshack I, Schachter J, Wargo JA, Koren O, Markel G, Boursi B. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science. 2021 Feb 5;371(6529):602-609. doi: 10.1126/science.abb5920. Epub 2020 Dec 10.

  PMID: 33303685 RESULT

• Cammarota G, Ianiro G, Kelly CR, Mullish BH, Allegretti JR, Kassam Z, Putignani L, Fischer M, Keller JJ, Costello SP, Sokol H, Kump P, Satokari R, Kahn SA, Kao D, Arkkila P, Kuijper EJ, Vehreschild MJG, Pintus C, Lopetuso L, Masucci L, Scaldaferri F, Terveer EM, Nieuwdorp M, Lopez-Sanroman A, Kupcinskas J, Hart A, Tilg H, Gasbarrini A. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019 Dec;68(12):2111-2121. doi: 10.1136/gutjnl-2019-319548. Epub 2019 Sep 28.

  PMID: 31563878 RESULT

• Ianiro G, Mullish BH, Kelly CR, Kassam Z, Kuijper EJ, Ng SC, Iqbal TH, Allegretti JR, Bibbo S, Sokol H, Zhang F, Fischer M, Costello SP, Keller JJ, Masucci L, van Prehn J, Quaranta G, Quraishi MN, Segal J, Kao D, Satokari R, Sanguinetti M, Tilg H, Gasbarrini A, Cammarota G. Reorganisation of faecal microbiota transplant services during the COVID-19 pandemic. Gut. 2020 Sep;69(9):1555-1563. doi: 10.1136/gutjnl-2020-321829. Epub 2020 Jul 3.

  PMID: 32620549 RESULT

• El-Salhy M, Hatlebakk JG, Gilja OH, Brathen Kristoffersen A, Hausken T. Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study. Gut. 2020 May;69(5):859-867. doi: 10.1136/gutjnl-2019-319630. Epub 2019 Dec 18.

  PMID: 31852769 RESULT

• Youngster I, Mahabamunuge J, Systrom HK, Sauk J, Khalili H, Levin J, Kaplan JL, Hohmann EL. Oral, frozen fecal microbiota transplant (FMT) capsules for recurrent Clostridium difficile infection. BMC Med. 2016 Sep 9;14(1):134. doi: 10.1186/s12916-016-0680-9.

  PMID: 27609178 RESULT

• Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.

  PMID: 25322359 RESULT

• Nash AK, Auchtung TA, Wong MC, Smith DP, Gesell JR, Ross MC, Stewart CJ, Metcalf GA, Muzny DM, Gibbs RA, Ajami NJ, Petrosino JF. The gut mycobiome of the Human Microbiome Project healthy cohort. Microbiome. 2017 Nov 25;5(1):153. doi: 10.1186/s40168-017-0373-4.

  PMID: 29178920 RESULT

• Quince C, Walker AW, Simpson JT, Loman NJ, Segata N. Shotgun metagenomics, from sampling to analysis. Nat Biotechnol. 2017 Sep 12;35(9):833-844. doi: 10.1038/nbt.3935.

  PMID: 28898207 RESULT

• Langmead B, Salzberg SL. Fast gapped-read alignment with Bowtie 2. Nat Methods. 2012 Mar 4;9(4):357-9. doi: 10.1038/nmeth.1923.

  PMID: 22388286 RESULT

• Kao D, Roach B, Silva M, Beck P, Rioux K, Kaplan GG, Chang HJ, Coward S, Goodman KJ, Xu H, Madsen K, Mason A, Wong GK, Jovel J, Patterson J, Louie T. Effect of Oral Capsule- vs Colonoscopy-Delivered Fecal Microbiota Transplantation on Recurrent Clostridium difficile Infection: A Randomized Clinical Trial. JAMA. 2017 Nov 28;318(20):1985-1993. doi: 10.1001/jama.2017.17077.

  PMID: 29183074 RESULT

• Beghini F, McIver LJ, Blanco-Miguez A, Dubois L, Asnicar F, Maharjan S, Mailyan A, Manghi P, Scholz M, Thomas AM, Valles-Colomer M, Weingart G, Zhang Y, Zolfo M, Huttenhower C, Franzosa EA, Segata N. Integrating taxonomic, functional, and strain-level profiling of diverse microbial communities with bioBakery 3. Elife. 2021 May 4;10:e65088. doi: 10.7554/eLife.65088.

  PMID: 33944776 RESULT

• Vernocchi P, Marini F, Capuani G, Tomassini A, Conta G, Del Chierico F, Malattia C, De Benedetti F, Martini A, Dallapiccola B, van Dijkhuizen EHP, Miccheli A, Putignani L. Fused Omics Data Models Reveal Gut Microbiome Signatures Specific of Inactive Stage of Juvenile Idiopathic Arthritis in Pediatric Patients. Microorganisms. 2020 Oct 6;8(10):1540. doi: 10.3390/microorganisms8101540.

  PMID: 33036309 RESULT

• Zhang X, Li L, Mayne J, Ning Z, Stintzi A, Figeys D. Assessing the impact of protein extraction methods for human gut metaproteomics. J Proteomics. 2018 May 30;180:120-127. doi: 10.1016/j.jprot.2017.07.001. Epub 2017 Jul 10.

  PMID: 28705725 RESULT

• Distler U, Kuharev J, Navarro P, Tenzer S. Label-free quantification in ion mobility-enhanced data-independent acquisition proteomics. Nat Protoc. 2016 Apr;11(4):795-812. doi: 10.1038/nprot.2016.042. Epub 2016 Mar 24.

  PMID: 27010757 RESULT

• Marzano V, Pane S, Foglietta G, Levi Mortera S, Vernocchi P, Onetti Muda A, Putignani L. Mass Spectrometry Based-Proteomic Analysis of Anisakis spp.: A Preliminary Study towards a New Diagnostic Tool. Genes (Basel). 2020 Jun 24;11(6):693. doi: 10.3390/genes11060693.

  PMID: 32599802 RESULT

• Cheng K, Ning Z, Zhang X, Li L, Liao B, Mayne J, Stintzi A, Figeys D. MetaLab: an automated pipeline for metaproteomic data analysis. Microbiome. 2017 Dec 2;5(1):157. doi: 10.1186/s40168-017-0375-2.

  PMID: 29197424 RESULT

• Alonso-Betanzos A, Bolon-Canedo V. Big-Data Analysis, Cluster Analysis, and Machine-Learning Approaches. Adv Exp Med Biol. 2018;1065:607-626. doi: 10.1007/978-3-319-77932-4_37.

  PMID: 30051410 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative; Metabolic Syndrome

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Gianluca Ianiro, MD, PhD

CONTACT

0630159539; gianluca.ianiro@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 28, 2025
• Study Start: April 23, 2026
• Primary Completion (Estimated): January 19, 2029
• Study Completion (Estimated): February 19, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Data will be given upon reasonable request to the PI.

Locations

IT (1)