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Can a special diet calm your gut? new study tests food as medicine for Crohn's and colitis

NCT ID NCT02412553

Disease control Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether two special diets—the specific carbohydrate diet or an elemental (liquid) diet—can help people with active Crohn's disease or ulcerative colitis feel better. Forty adults will choose one diet and follow it for 6 weeks, while researchers track symptoms, inflammation, and gut bacteria changes. The goal is to see if diet alone can bring the disease under control.

What this could mean

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

Active substance
specific carbohydrate diet or elemental diet (enteral nutrition)
What this could lead to
If it works, this could point toward a dietary approach to manage Crohn's disease or ulcerative colitis without relying solely on medication.
What could go wrong
This is a small, early study with only 40 people and no placebo group, so results may not apply widely. Diets can be hard to follow long-term, and the effect on disease may be modest or temporary.

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 40 people

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

Started

Oct 2014

Expected to finish

Oct 2026

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 90 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. At least 18 years of age 2. Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol. 3. Established diagnosis of small bowel or colonic CD or ulcerative colitis 4. Confirmation of active CD or UC with recent (within 1 month) objective evidence of active disease on colonoscopy 5. Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids. 6. Current disease activity defined as a Harvey Bradshaw index \> 4 at baseline (week 0) or SCCAI \> 3 Exclusion Criteria: 1. If female, is pregnant or is breast feeding 2. Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies) 3. Inability to provide informed consent or unwilling to participate 4. Evidence of untreated infection e.g. clostridium difficile 5. Presence of stoma or J pouch 6. Presence of enterocutaneous, abdominal or pelvic fistulae with abscesses or fistulae likely to require surgery during the study period 7. Bowel surgery within 12 weeks prior to screen and/or has surgery planned or deemed likely for IBD during the study period 8. Fixed symptomatic stenosis of small bowel or colon 9. Chronic use of narcotics for chronic pain defined as a daily use of one or more doses of narcotic containing medication 10. Use of oral or intravenous antibiotics within 4 weeks prior to screening 11. Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 2 weeks prior to screening.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

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

Crohn's disease

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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