Anorexia NervosaAN-BUTIXNCT07289581
Effect of Treatment With Butyric Acid in Anorexia Nervosa
A study testing Dietary Supplement: Butyric Acid in people with Anorexia Nervosa and Gut Microbiota, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anorexia Nervosa, Gut Microbiota, Weight Trajectory
- What is being tested?
- Dietary Supplement: Butyric Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2025to 12 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi
Florence, FI, 50134
About this study
Official title: Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa
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:
Read more
- 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
- Anorexia Nervosa, Gut Microbiota, Weight Trajectory
- Being tested
- Dietary Supplement: Butyric Acid
- Keywords
- anorexia nervosa, gut microbiota, butyric acid, outcome
- Medical subject headings
- Anorexia Nervosa, Body-Weight Trajectory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Butyric AcidDietary 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).
Dietary Supplement: Butyric AcidDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Butyric Acid | Active comparator | Participants with anorexia nervosa receiving butyric acid supplementation plus Treatment As Usual. Receives: Dietary Supplement: Dietary Supplement: Butyric Acid |
| Placebo Comparator: Placebo | Placebo comparator | Participants with anorexia nervosa receiving placebo capsules plus Treatment As Usual. Receives: Dietary Supplement: Dietary Supplement: Butyric Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Body weight measured in kilograms using a calibrated scale.
Measured: Baseline and 3 months
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²
Measured: 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.
Measured: 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.
Measured: Baseline and 3 months
Secondary outcomes (5)
Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015)
The EDE-Q measures eating-disorder psychopathology across four subscales: Restraint, Eating Concern, Shape Concern, and Weight Concern. Items are scored from 0 to 6. The Global Score is the mean of the four subscales. Higher scores indicate more severe eating-disorder symptoms. Unit of Measure: Units on a scale.
Measured: Baseline and 3 months
Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011)
The EDI-3 evaluates psychological traits associated with eating disorders. It includes subscales such as Drive for Thinness, Bulimia, Body Dissatisfaction, Low Self-Esteem, Emotional Dysregulation, Interoceptive Deficits, Perfectionism, Asceticism, and others. Items are typically scored on 0-4 Likert scales. Higher scores indicate greater psychological dysfunction relevant to EDs. Unit of Measure: Units on a scale.
Measured: Baseline and 3 months
General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983)
The BSI assesses general psychopathology. It includes the following subscales: Somatization, Obsessive-Compulsive Symptoms, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism. Items are rated on a 0-4 scale. Higher scores indicate greater overall psychopathology. Unit of Measure: Units on a scale.
Measured: Baseline and 3 months
Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)
The CTQ-SF assesses exposure to childhood maltreatment. It includes five subscales: Emotional Abuse, Physical Abuse, Sexual Abuse, Emotional Neglect, and Physical Neglect. Subscale scores range from 5 to 25; the total score ranges from 25 to 125. Higher scores indicate more severe childhood maltreatment. Unit of Measure: Units on a scale.
Measured: Baseline
Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
The DERS measures emotion-regulation difficulties. It includes six subscales: Nonacceptance, Goals, Impulse, Awareness, Strategies, and Clarity. Total scores range from 36 to 180. Higher scores indicate greater difficulties in emotion regulation. Unit of Measure: Units on a scale
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start12 Nov 2025
- Primary completion12 Nov 2026 (estimated)
- Study completion12 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Castellini, Medical Degree, Principal investigator, Department of Health Sciences, University of Florence, Florence, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289581
- Sponsor's protocol ID
- 29252_spe
- Other IDs
- 29252
- Acronym
- AN-BUTIX
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37884972Mack 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.
PubMed 27229737Hata 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.
PubMed 31504398Facchin 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.
PubMed 32476236Castellini 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.
PubMed 37474544
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effetto Del Trattamento Con Acido Butirrico Sull'Anoressia Nervosa
- ClinicalTrials.gov ID
- NCT07289581
- Acronym / sponsor ID
- AN-BUTIX / 29252_spe
- Conditions
- Anorexia Nervosa, Gut Microbiota, Weight Trajectory
- Keywords
- anorexia nervosa, gut microbiota, butyric acid, outcome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 12 Nov 2028 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Butyric Acid | Active comparator | Dietary Supplement: Dietary Supplement: Butyric AcidParticipants with anorexia nervosa receiving butyric acid supplementation plus Treatment As Usual. |
| Placebo Comparator: Placebo | Placebo comparator | Dietary Supplement: Dietary Supplement: Butyric AcidParticipants with anorexia nervosa receiving placebo capsules plus Treatment As Usual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Supplement: Butyric AcidDaily 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 | Active Comparator: Butyric Acid |
| Dietary Supplement: Butyric AcidDaily 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. | Dietary supplement | Placebo Comparator: Placebo |
Primary outcome
Weight
Time frame: Baseline and 3 months
Body weight measured in kilograms using a calibrated scale.
Body Mass Index (BMI)
Time frame: Baseline and 3 months
BMI calculated as weight (kg) divided by height (m²). Unit of Measure: kg/m²
Gut Microbiota Composition
Time frame: Baseline and 3 months
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.
Short-Chain Fatty Acids (SCFAs)
Time frame: Baseline and 3 months
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.
5 secondary outcomes
Eating disorder psychopatology - Eating Disorder Examination Questionnaire 6.0 (EDE-Q 6.0; Calugi et al., 2015)
Time frame: Baseline and 3 months
Eating disorder psychopathology - Eating Disorder Inventory - 3 (EDI-3; Clausen et al., 2011)
Time frame: Baseline and 3 months
General psychopathology - Brief Symptom Inventory (BSI); Derogatis & Melisaratos, 1983)
Time frame: Baseline and 3 months
Childhood maltreatment - Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein et al., 2003)
Time frame: Baseline
Emotional dysregulation - Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 37884972Quagebeur 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.
- Background: PubMed 27229737Mack 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.
- Background: PubMed 31504398Hata 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.
- Results publication: PubMed 32476236Facchin 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.
- Results publication: PubMed 37474544Castellini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Castellini, Medical Degree principal investigator
Department of Health Sciences, University of Florence, Florence, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Butyric Acid in people with Anorexia Nervosa and Gut Microbiota, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07289581, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.