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Could a gut supplement help anorexia patients gain weight?

NCT ID NCT07289581

Disease control Sponsor: Azienda Ospedaliero-Universitaria Careggi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a daily butyric acid supplement can help people with anorexia nervosa gain weight faster when added to standard treatment (nutritional therapy and counseling). Fifty women aged 18-65 will receive either butyric acid or a placebo for 3 months. Researchers will track weight, BMI, eating disorder symptoms, and gut bacteria changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
butyric acid (a dietary supplement)
What this could lead to
If it works, this could point toward a safe, affordable supplement to help people with anorexia gain weight faster when combined with standard care.
What could go wrong
This is a small, early-stage trial with only 50 participants. The supplement may show no benefit over placebo, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

anorexia nervosa Body-Weight Trajectory

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anorexia nervosa Gut microbiota Weight trajectory

Contacts and locations

Locations

  • SODc Psichiatria, Azienda Ospedaliero-Universitaria Careggi

    Florence, FI, 50134, Italy

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