RECRUITINGINTERVENTIONAL

Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease

Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

OTHER

Intermittent caloric restriction

Intermittente caloric restriction: 1. st month: restriction of 50% of the caloric intake previously determined by the dietician 1 day per week 2. nd month: restriction of 50% of the caloric intake 2 days per week 3. rd month: restriction of 60% of the caloric intake 2 days per week 4. th month: restriction of 75% of the caloric intake 2 days per week

Locations (1)

CHRU of Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, France