Effect of Treatment With Butyric Acid in Anorexia Nervosa

NCT07289581 | Active Not Recruiting DMC

• 2 other identifiers: 29252_spe29252
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the therapeutic potential of oral butyric acid supplementation in individuals with anorexia nervosa (AN). T The study will assess whether butyric acid, administered alongside standard multidisciplinary care, improves weight restoration and contributes to overall clinical recovery. The primary objectives are to determine: \- Whether butyric acid enhances weight restoration during the first 3 months of treatment. Participants will be randomly assigned to receive either butyric acid or a placebo for 3 months, in addition to treatment-as-usual, which includes nutritional rehabilitation and cognitive-behavioral therapy. Throughout the study, researchers will monitor:

• Changes in body weight and Body Mass Index (BMI)
• General and eating-disorder-related psychopathology
• Blood-based biomarkers related to inflammation, metabolism, and neuroendocrine function
• Gut microbiota composition and metabolites, including short-chain fatty acids A total of 50 participants with AN are expected to be enrolled.

Conditions

Gut Microbiota; Weight Trajectory; Anorexia Nervosa

Keywords

anorexia nervosa; gut microbiota; butyric acid; outcome

Outcome Measures

Primary Outcomes (4)

• Weight

  Body weight measured in kilograms using a calibrated scale.

  Baseline and 3 months

• Body Mass Index (BMI)

  BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²

  Baseline and 3 months

• Gut Microbiota Composition

  Assessment of the relative abundance of bacterial taxa through sequencing at baseline and 3 months. Changes over time will be evaluated to identify shifts in microbial composition and potential alterations in gut balance relevant to anorexia nervosa.

  Baseline and 3 months

• Short-Chain Fatty Acids (SCFAs)

  Measurement of SCFA concentrations (e.g., butyrate, acetate, propionate) at baseline and 3 months. Changes in SCFA levels will be used to evaluate alterations in gut microbial metabolic activity over time.

  Baseline and 3 months

Secondary Outcomes (5)

• Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015)

  Baseline and 3 months

• Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011)

  Baseline and 3 months

• General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983)

  Baseline and 3 months

• Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)

  Baseline

• Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

  Baseline and 3 months

Other Outcomes (3)

• Inflammatory Biomarkers (pg/mL)

  Baseline and 3 months

• C-Reactive Protein (CRP)

  Baseline and 3 months

• Metabolic Biomarkers (mg/dL)

  Baseline and 3 months

Study Arms (2)

Active Comparator: Butyric Acid

ACTIVE COMPARATOR

Participants with anorexia nervosa receiving butyric acid supplementation plus Treatment As Usual.

Dietary Supplement: Dietary Supplement: Butyric Acid

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Participants with anorexia nervosa receiving placebo capsules plus Treatment As Usual.

Dietary Supplement: Dietary Supplement: Butyric Acid

Interventions

Dietary Supplement: Butyric Acid DIETARY_SUPPLEMENT

Daily oral supplementation with 2 capsules of microencapsulated butyric acid (Butyrose®, 550 mg each; total daily dose 1,100 mg) for 3 months, administered in addition to Treatment As Usual (nutritional rehabilitation + cognitive-behavioral therapy).

Active Comparator: Butyric Acid

Eligibility Criteria

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

You may qualify if:

• Female sex
• Age 18-65 years
• Current diagnosis of Anorexia Nervosa (DSM-5)
• Able and willing to provide informed consent
• Ability to comply with study procedures and assessments

You may not qualify if:

• Severe psychiatric conditions requiring inpatient hospitalization (e.g., psychosis, severe major depressive episode with suicidal intent)
• Severe medical conditions requiring inpatient care (cardiovascular, renal, hematopoietic, gastrointestinal, endocrine disorders)
• Intellectual disability, illiteracy, or conditions impairing consent or questionnaire completion
• Current participation in another experimental protocol
• Active use of probiotics
• Neutropenia (\<0.5 × 10\^9/L)
• Leukocytosis (\>30 × 10\^9/L)
• Fever \> 38°C
• Radiological evidence of toxic megacolon or intestinal perforation
• Presence of colostomy
• Severe comorbidity limiting 30-day survival
• Active or past malignancy requiring chemotherapy
• Corticosteroid therapy within the past 6 months
• HIV infection

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (1)

SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi

Florence, FI, 50134, Italy

Location

Related Publications (5)

• Quagebeur R, Dalile B, Raes J, Van Oudenhove L, Verbeke K, Vrieze E. The role of short-chain fatty acids (SCFAs) in regulating stress responses, eating behavior, and nutritional state in anorexia nervosa: protocol for a randomized controlled trial. J Eat Disord. 2023 Oct 26;11(1):191. doi: 10.1186/s40337-023-00917-6.

  PMID: 37884972 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

• 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

• Facchin S, Vitulo N, Calgaro M, Buda A, Romualdi C, Pohl D, Perini B, Lorenzon G, Marinelli C, D'Inca R, Sturniolo GC, Savarino EV. Microbiota changes induced by microencapsulated sodium butyrate in patients with inflammatory bowel disease. Neurogastroenterol Motil. 2020 Oct;32(10):e13914. doi: 10.1111/nmo.13914. Epub 2020 May 31.

  PMID: 32476236 RESULT

• Castellini G, Cassioli E, Vitali F, Rossi E, Dani C, Melani G, Flaccomio D, D'Andria M, Mejia Monroy M, Galli A, Cavalieri D, Ricca V, Bartolucci GL, De Filippo C. Gut microbiota metabolites mediate the interplay between childhood maltreatment and psychopathology in patients with eating disorders. Sci Rep. 2023 Jul 20;13(1):11753. doi: 10.1038/s41598-023-38665-x.

  PMID: 37474544 RESULT

MeSH Terms

Conditions

Anorexia Nervosa; Body-Weight Trajectory

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giovanni Castellini, Medical Degree

  Department of Health Sciences, University of Florence, Florence, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 17, 2025
• Study Start: November 12, 2025
• Primary Completion (Estimated): November 12, 2026
• Study Completion (Estimated): November 12, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)