NCT05683730 Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
| NCT ID | NCT05683730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 174 participants |
| Start Date | 2023-04-18 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 174 participants in total. It began in 2023-04-18 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. CD is a common inflammatory bowel disease (IBD), frequent (150,000 patients in France and 1.5 million in Europe), disabling and incurable. The environmental factors, and in particular diet, play a major role in the pathogenesis of CD. The prevalence of CD is steadily increasing in highly industrialized countries, where the Western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. On the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of CD, especially in pediatrics. There are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of IBD. To date, and despite patient concern, there is no consensus nutritional in the management of CD to influence the natural course of the disease. The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with CD.
Eligibility Criteria
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.
Contact & Investigator
CARON Bénédicte, MD
PRINCIPAL INVESTIGATOR
CHRU of Nancy, Hepatogastroenterology Department
Frequently Asked Questions
Who can join the NCT05683730 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05683730 currently recruiting?
Yes, NCT05683730 is actively recruiting participants. Contact the research team at b.caron@chru-nancy.fr for enrollment information.
Where is the NCT05683730 trial being conducted?
This trial is being conducted at Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT05683730 clinical trial?
NCT05683730 is sponsored by Central Hospital, Nancy, France. The principal investigator is CARON Bénédicte, MD at CHRU of Nancy, Hepatogastroenterology Department. The trial plans to enroll 174 participants.
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