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Gut bacteria cocktail shows promise for autism GI troubles

NCT ID NCT02504554

Disease control Sponsor: Arizona State University 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a combination therapy—including antibiotics, a bowel cleanse, stomach acid suppressants, and beneficial bacteria from human feces—to treat gastrointestinal problems in 18 children with autism. The goal was to see if the treatment could reduce gut symptoms like pain and bloating. The trial was small and early-stage, so results are preliminary.

What this could mean

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

Active substance
beneficial bacteria (fecal transplant) along with antibiotics, bowel cleanse, and stomach acid suppressant
What this could lead to
If it works, this could point toward a treatment for gastrointestinal problems in children with autism, potentially easing related symptoms.
What could go wrong
This is a very small, early-phase trial with only 18 participants, so results may not apply to everyone. The combination therapy involves multiple steps and may cause discomfort or side effects.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

18 people

The number who actually took part.

Start date

Jul 2014

Finished

Apr 2016

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

7 to 17 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: 1. Children ages 7-17 years 2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R) 3. Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4 items 4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during clinical trial 5. General good physical health aside from gastrointestinal problems 6. Cognitive Ability to Provide Informed Assent Exclusion Criteria: 1. Antibiotics in last 6 months 2. Probiotics in last 3 months 3. Single-gene disorder (Fragile X, etc.) 4. Major brain malformation 5. Tube feeding 6. Severe gastrointestinal problems that require immediate treatment (life-threatening) 7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions 8. Severely underweight/malnourished 9. Recent or scheduled surgeries 10. Current participation in other clinical trials

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder

As listed by the trial registrant

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

Autism spectrum disorders Gastrointestinal problems

More trials for these conditions

Other studies related to the condition(s) this trial covers.