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Poop pills for autism? small study tests gut bacteria fix

NCT ID NCT07371013

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether fecal microbiota transplantation (FMT) capsules can improve gut symptoms like constipation and diarrhea in children with autism, and possibly help their behavior. Twenty children aged 6-12 will be randomly assigned to receive either FMT capsules or a placebo after bowel cleansing. The study lasts about 6 months and tracks stool consistency, pain, and behavioral changes.

What this could mean

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

Active substance
Fecal microbiota transplantation (FMT) capsules (MBiotix HBI Caps) containing gut bacteria from healthy donors
What this could lead to
If it works, this could point toward a new way to ease gut problems and possibly improve behavior in children with autism.
What could go wrong
This is a very small, early pilot study with only 20 children. It may not show clear benefits, and the effects could vary widely. Bowel cleansing is required, which can be uncomfortable.

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 20 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

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

6 to 12 years

Sex

Anyone

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: * Providing informed consent for participation in the study by the child's legal representative - parent or legal guardian. * Diagnosis of autism spectrum disorder according to DSM-5 or ICD-11 criteria. * Ability to swallow an empty test capsule identical in shape and size to the investigational product * Abnormal stool consistency observed by parents for at least 2 months prior to study inclusion. Patients with an average stool consistency greater than 5 on the Bristol Stool Form Scale (BSFS) during the baseline period will be classified as having diarrhea. Patients with an average stool consistency less than 3 on the Bristol Stool Form Scale during the baseline period will be classified as having constipation. Exclusion Criteria: * Presence of a gastrointestinal disease such as celiac disease, food allergy, inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease of the stomach or duodenum, Hirschsprung's disease. * Primary or secondary immunodeficiency, including absolute neutrophil count in peripheral blood \<1500 measured within 28 days prior to planned FMT. * History of surgery involving disruption of intestinal continuity within 3 months prior to study inclusion. * Lactose or fructose intolerance. Patients with lactose intolerance who follow an elimination diet and still experience symptoms may be included in the study. * Malnutrition defined as Body Mass Index (BMI) below the 3rd percentile based on Polish growth charts from 2010. * Overweight or obesity defined as BMI above the 85th percentile based on Polish growth charts from 2010. * Active infection requiring antibiotic therapy. * Expected use of antibiotics during participation in the study. * Use of probiotics during participation in the study. * Inability to undergo bowel cleansing therapy (Dicopeg Endo). * Inability to swallow an empty test capsule. * Lack of consent from the child's legal representative - parent or legal guardian - for participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Institute of Mother and Child

    Warsaw, Masovian Voivodeship, 01-211, Poland

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