Effect of Treatment With Butyric Acid in Anorexia Nervosa
NCT ID: NCT07289581
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2025-11-12
2028-11-12
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active Comparator: Butyric Acid
Participants with anorexia nervosa receiving butyric acid supplementation plus Treatment As Usual.
Dietary Supplement: Butyric Acid
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).
Placebo Comparator: Placebo
Participants with anorexia nervosa receiving placebo capsules plus Treatment As Usual.
Dietary Supplement: Butyric Acid
Daily oral supplementation with 2 placebo capsules matched in appearance and composition (maltodextrins, cellulose, inert excipients), administered for 3 months in addition to Treatment As Usual.
Interventions
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Dietary Supplement: Butyric Acid
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).
Dietary Supplement: Butyric Acid
Daily oral supplementation with 2 placebo capsules matched in appearance and composition (maltodextrins, cellulose, inert excipients), administered for 3 months in addition to Treatment As Usual.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Principal Investigators
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Giovanni Castellini, Medical Degree
Role: PRINCIPAL_INVESTIGATOR
Department of Health Sciences, University of Florence, Florence, Italy
Locations
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SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi
Florence, FI, Italy
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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29252
Identifier Type: REGISTRY
Identifier Source: secondary_id
29252_spe
Identifier Type: -
Identifier Source: org_study_id