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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHRU of Nancy
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
CARON Bénédicte, MD
b.caron@chru-nancy.fr
0383155580
Backup
Ludivine ODOUL, CPM
l.odoul@chru-nancy.fr
0383155580
Time Frame
Start Date: 2023-04-18
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 174
Treatments
Experimental: Intermittent caloric restriction
Intermittent caloric restriction during 16 weeks.
No_intervention: Routine practice
Routine practice
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov