NCT05683730Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 174 (estimated)
- First submitted
- 20 Dec 2022
- Start date
- 18 Apr 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Central Hospital, Nancy, France
- Diseases
- Crohn's disease
- NCT number
- NCT05683730
What you commit to
- Study type: Interventional
- Planned participants: 174
- From 18 Apr 2023 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU of NANCY Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.