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Could an Anti-Inflammatory diet designed for Crohn's disease also tame IBS?

NCT ID NCT07707635

Disease control Sponsor: Ariel University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests whether a modified version of the Crohn's Disease Exclusion Diet (CDED) can ease symptoms of non-constipation irritable bowel syndrome (IBS) better than the standard low FODMAP diet. About 150 adults with moderate-to-severe IBS will follow one of the two diets for six weeks. Researchers will track symptom changes, gut inflammation, and microbiome health to see if the CDED offers added benefits beyond symptom relief.

What this could mean

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

Active substance
a modified Crohn's Disease Exclusion Diet (CDED) adapted for IBS, excluding the enteral formula
What this could lead to
If effective, the modified CDED could offer a new dietary option for people with IBS that targets inflammation and gut health, potentially improving symptoms and quality of life.
What could go wrong
This is a relatively small, early-stage study, and the modified CDED may not prove superior to the standard low FODMAP diet. Dietary interventions can be hard to follow, and results may not apply to everyone with IBS.

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 150 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 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: * Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria. * Moderate-to-severe symptoms (IBS-SSS score ≥175). * Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics Exclusion Criteria: * Coexisting GI diseases \[e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease \[positive transglutaminase (TTG) serology\]. * Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease \[abnormal Thyroid-Stimulating Hormone (TSH)\], and bariatric surgery. * Recent intestinal resection. * Pregnancy or breastfeeding. * Known food allergies. * Current active eating disorder * Participants already following a restrictive diet, including diets that overlap with the interventions in this study, will be excluded to prevent confounding effects on gut microbiota composition and gastrointestinal symptoms, and to ensure consistent baseline conditions. However, individuals who have discontinued such diets at least two to four weeks prior to enrollment may be eligible, allowing for a sufficient dietary washout period to minimize residual effects on the gut microbiota. * Currently under obesity management medication treatment. * Vegans * Use of antibiotics within the 4 weeks prior to enrollment or during the study period. * Abnormal hemoglobin levels (for women\<11.5 gr/dl, for men\<13 gr/dl)29 * Baseline CRP≥5

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Conditions

The condition(s) this trial relates to.

alpha 1-antitrypsin deficiency irritable bowel syndrome

As listed by the trial registrant

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

Irritable bowel syndrome (IBS)

How to take part

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  1. The official record

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