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Could the gut microbiome hold clues to eating disorder recovery?

NCT ID NCT07066033

Knowledge-focused Sponsor: Esther Nova Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This observational study looks at whether the bacteria in the gut are linked to eating disorders in children and teenagers. Researchers will compare the gut microbiome, diet, and psychological factors between young patients with eating disorders and healthy peers. They will also track patients for a year to see if any baseline measures predict treatment response. The goal is to better understand the connection between the gut and brain in these conditions.

What this could mean

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

What this could lead to
If successful, this could point toward gut-based biomarkers that help predict how young patients with eating disorders respond to treatment.
What could go wrong
This is an observational study, so it cannot prove cause and effect. Results may not lead to direct treatments, and findings might not apply beyond the specific group studied.

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.

Participants

About 158 people

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

Started

Aug 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

All patients will be recruited in the ED specialized unit of the Niño Jesus University Children Hospital (NJUCH) after receiving a DSM-V ED diagnosis by an experienced psychiatrist. Patients will be eligible on treatment modalities including hospitalization, outpatient consultations or home hospitalization. The control group will be recruited among healthy children and adolescents attending eligible levels in private and public centers of formal education. Eligible educational centers are those located in geographical areas included in the administrative health zones assigned to the NJUCH. A combination of private and public schools from both metropolitan and peripheral cities is being selected. Invitation letters are sent to the head of the schools and following acceptance, randomization of age levels across schools is performed.

Ages

7 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age: 7-17.9 years * Diagnosis of Anorexia Nervosa, both restrictive (ANR) and binge-purging (ANBP) subtypes, Other Specified Feeding and Eating Disorders (OSFED), Avoidant/Restrictive Food Intake Disorder (ARFID) according to DSM-V (APA, 2013). * Males and females * First episode or less than 1 year evolution since initial symptoms * Written informed consent by parent/tutor and also by the adolescent if age is more than 12 y. Exclusion Criteria: * Comorbidities: Current infectious disease at admission; Severe neurodevelopmental disorders with impaired language development; Moderate or severe intellectual disability; Endocrine disorders such as diabetes mellitus or thyroid disease; Celiac disease; Suicidal behaviors in the previous 3 months. * Patients with previous unsuccessful treatments for more than one year. * Use of the following medications before entering the study: laxatives, anabolic steroids, immunosuppressant drugs, Helicobacter pylori eradication treatment, thyroid hormones or antibiotic treatment in the previous two months * Surgery in the previous month. Control group participants' exclusion criteria are the same plus the following: History with diagnosis of mental disease (including EDs). Current autoimmune or infectious disease.

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Conditions

The condition(s) this trial relates to.

anorexia nervosa avoidant/restrictive food intake disorder eating disorder Feeding and Eating Disorders Inflammation

As listed by the trial registrant

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

Eating disorders in adolescence Eating disorders in children

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Infantil Universitario Niño Jesús

    RECRUITING

    Madrid, Madrid, 28009, Spain

  • Institute of Food Science and Technology and Nutrition (ICTAN, CSIC)

    RECRUITING

    Madrid, Madrid, 28040, Spain

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