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Could a diet change calm IBD by reshaping gut bacteria?

NCT ID NCT04757181

Disease control Sponsor: University of Massachusetts, Worcester 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests whether a specific diet, called the IBD-AID, can improve symptoms of inflammatory bowel disease (IBD) by changing the bacteria in the gut. Participants aged 15 and older with IBD will follow the diet for 8 weeks, with guidance from study staff and cooking classes. Researchers will measure changes in gut microbes, inflammation in the blood, and symptom severity to see if the diet helps.

What this could mean

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

Active substance
a dietary intervention called the IBD-AID (Inflammatory Bowel Disease Anti-Inflammatory Diet)
What this could lead to
If successful, this diet could offer a safe, drug-free way to manage IBD symptoms and improve quality of life.
What could go wrong
This is a small, early study without a control group, so results may not apply to everyone. Dietary changes can be hard to maintain, and the diet may not work for all types of IBD.

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

38 people

The number who actually took part.

Started

Feb 2017

Finished

Jun 2019

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

15 years and older

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: * \- 15 years of age or older * Willingness and capacity to significantly change diet * Willing and able to comply with scheduled visits, blood, and stool collection, and other study procedures and to complete the study * Clinical provider (GI clinician) permission for IBD patients to participate in the intervention is required for participation in the study. * Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. * For children age 15 and above, the assent of the child and consent of a parent or legal guardian will be required. * One of the following: * diagnosis of IBD, specifically Crohn's Disease and Ulcerative Colitis * healthy control Exclusion Criteria: * the presence of infection (such as C.diff) precipitating the colitis * antibiotics taken within 3 months of study entry * medically unstable to give consent * on heparin or Coumadin * Prisoners * Subjects who do not speak or understand English, to ensure that there is consistency in teaching and educational materials. * Subjects who self-report current pregnancy * Patients who do not receive clinical care at UMass Memorial Health Care

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases

Contacts and locations

Locations

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655, United States

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