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NCT05683730
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Conditions: Crohn's Disease
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 174
Sponsor: Central Hospital, Nancy, France
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 oldEstablished diagnosis of Crohn's disease with a minimum disease duration of 3 monthsPatient with mild to moderate Crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a CDAI score between 150 to 300Medical treatment of Crohn's disease stable for at least 3 monthsPatient compliant with an intermittent caloric restriction during 16 weeksPerson affiliated to or beneficiary of a social security planPerson informed about study organization and having signed the informed consentExclusion Criteria:Patient with a BMI < 18.5kg/m2Patient having a weight loss of 5% the first month and 10% during the first 6 monthsPatient with active ano-perineal lesionsPatient with an ostomyPatient 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 womanMinor person (non-emancipated)Adult person under legal protection (any form of public guardianship)Adult person incapable of giving consent and not under legal protectionPerson deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.
Source: ClinicalTrials.gov (NCT05683730). StuddyBuddy aggregates publicly available trial information.