Could a tailored diet beat standard care for Crohn's flare-ups?
NCT ID NCT06953791
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares quality of life in adults with Crohn's disease during a flare when treated either with standard care or an adapted Crohn's disease exclusion diet plus partial enteral nutrition. The diet limits certain foods and uses a nutritional drink (Modulen) to help control inflammation. Researchers will track symptoms and well-being over 48 weeks to see if the diet approach offers better outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- adapted Crohn's disease exclusion diet with partial enteral nutrition (Modulen)
- What this could lead to
- If successful, this diet-based approach could offer a well-tolerated, drug-sparing option to manage Crohn's flares and improve quality of life.
- What could go wrong
- This is a small Phase 2 trial (52 participants), so results may not apply broadly. The diet is demanding, and adherence may be challenging.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Must be ≥ 18 years at the time of signing the informed consent. * Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy * Patients with a Crohn's disease activity index (CDAI) of ≥ 150 * Patients will not be excluded if they have received 5ASA or an immunomodulator for \> 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy * Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures * Able to adhere to the study visit schedule and other protocol requirements * All subjects must agree to refrain from donating blood while on study drugs * All subjects must agree not to share medication. * Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 28 days (male or female) after the end of treatment Exclusion Criteria: * Patients with with minimal disease activity (CDAI \<150) or severe disease (CDAI \>450) * Patients who have received corticosteroids of any kind in the previous 4 weeks * Patients who have started an immunomodulator in the previous 8 weeks * Any current biological or small molecule treatment * Isolated large bowel disease iinvolving the recto-sigmoid or descending colon * Patients with penetrating disease (abscess or fistula) * Active perianal disease * Fixed stricture or small bowel obstruction * Normal fecal calprotectin * Active extraintestinal disease (e.g. joint disease) * Patients who have undergone an intestinal resection * Sclerosing cholangitis * History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. * Women during pregnancy and lactation Participation in other clinical trials or observation period of competing trials.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Universitätsklinik Tübingen
RECRUITINGTübingen, 72076, Germany
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