Actively Recruiting
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Led by Central Hospital, Nancy, France · Updated on 2023-06-08
174
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 to 65 years old
- Established diagnosis of Crohn's disease with a minimum disease duration of 3 months
- Mild to moderate Crohn's disease defined by fecal calprotectin ≥ 250 µg/g and CDAI score between 150 to 300
- Medical treatment for Crohn's disease stable for at least 3 months
- Willingness to comply with intermittent caloric restriction for 16 weeks
- Affiliated with or beneficiary of a social security plan
- Informed about study details and signed informed consent
You will not qualify if you...
- Body mass index (BMI) below 18.5 kg/m2
- Weight loss of 5% in the first month or 10% within the first 6 months
- Presence of active ano-perineal lesions
- Having an ostomy
- History of eating disorders such as anorexia or bulimia
- Pregnant, breastfeeding, or parturient women
- Minors who are not legally emancipated
- Adults under any form of legal guardianship or incapable of giving consent without protection
- Persons deprived of liberty by judicial or administrative decision
- Persons under psychiatric care as defined by relevant public health laws
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHRU of Nancy
Vandœuvre-lès-Nancy, CHRU de Nancy, France, 54511
Actively Recruiting
Research Team
C
CARON Bénédicte, MD
CONTACT
L
Ludivine ODOUL, CPM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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