Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Key facts
- Where
- Vandœuvre-lès-Nancy, FranciaországSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in Franciaország
- CHRU of NANCYVandœuvre-lès-Nancy, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Central Hospital, Nancy, France
- Trial code
- NCT05683730
- Record updated
- 2023. június 8.
- Original description
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.Read full original descriptionShow less
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled 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.
Inclusion: 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: Patient with eating disorders (anorexia, bulimia); Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1; 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; 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.