Intermittent caloric restriction for patients with mild to moderate Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of intermittent caloric restriction on patients diagnosed with mild to moderate Crohn's disease, a chronic inflammatory condition of the gastrointestinal tract. The study aims to explore how dietary management, specifically caloric restriction, can influence the disease's progression and symptoms. Participants will adhere to a structured intermittent caloric restriction plan over a 16-week period while maintaining stable medical treatment for their condition. The trial seeks to fill the gap in nutritional management consensus for Crohn's disease, which is increasingly relevant given the rising prevalence of the condition in industrialized nations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients between 18 to 65 years old
* Established diagnosis of Crohn's disease with a minimum disease duration of 3 months
* Patient with mild to moderate Crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a CDAI score between 150 to 300
* Medical treatment of Crohn's disease stable for at least 3 months
* Patient compliant with an intermittent caloric restriction during 16 weeks
* Person affiliated to or beneficiary of a social security plan
* Person informed about study organization and having signed the informed consent

Exclusion Criteria:

* Patient with a BMI \< 18.5kg/m2
* Patient having a weight loss of 5% the first month and 10% during the first 6 months
* Patient with active ano-perineal lesions
* Patient with an ostomy
* Patient with eating disorders (anorexia, bulimia)
* Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:

  * Pregnant, parturient or breastfeeding woman
  * Minor person (non-emancipated)
  * Adult person under legal protection (any form of public guardianship)
  * Adult person incapable of giving consent and not under legal protection
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Where it's running

• CHRU of Nancy
  Vandœuvre-lès-Nancy, CHRU de Nancy, France Recruiting

Study contacts

• Principal investigator: CARON Bénédicte, MD — CHRU of Nancy, Hepatogastroenterology Department
• Study coordinator: CARON Bénédicte, MD
• Email: b.caron@chru-nancy.fr
• Phone: 0383155580

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SL-325 in Crohn's Disease: a phase 2 test for adults with moderate to severe disease

  This phase 2 study tests SL-325 against placebo in adults with moderately to severely active Crohn's disease to see if it helps improve symptoms and disease activity.

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• Tabellvi for moderate to severe Crohn's disease in Chinese adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.