Clinical trial NCT05683730: Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Official title: Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn's Disease
Keywords: intermittent caloric restriction
Crohn's disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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 Criteria:

* 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
* Patient 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 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
* Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1.

Primary outcomes:
measure: Intestinal inflammation
timeFrame: week 16
Secondary outcomes:
measure: Induction of a clinical response
timeFrame: week 16
measure: Induction of a clinical remission
timeFrame: week 16
measure: Induction of a biological remission
timeFrame: week 16
measure: Induction of a radiological response
timeFrame: week 16
measure: Improving quality of life
timeFrame: week 16
measure: Improving work productivity
timeFrame: week 16
measure: Improving fatigue
timeFrame: week 16
measure: Improving functional disability
timeFrame: week 16
measure: Improving anxiety disorder
timeFrame: week 16
measure: Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD.
timeFrame: weeks 4;8;12 and 16
measure: Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.
timeFrame: week 16
measure: Determine the level of patient satisfaction with intermittent caloric restriction
timeFrame: week 16
measure: Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction
timeFrame: 48 hours after intermittent caloric restriction
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU of Nancy
state: CHRU De Nancy
Study officials:
affiliation: CHRU of Nancy, Hepatogastroenterology Department
name: CARON Bénédicte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yanai H, Levine A, Hirsch A, Boneh RS, Kopylov U, Eran HB, Cohen NA, Ron Y, Goren I, Leibovitzh H, Wardi J, Zittan E, Ziv-Baran T, Abramas L, Fliss-Isakov N, Raykhel B, Gik TP, Dotan I, Maharshak N. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022 Jan;7(1):49-59. doi: 10.1016/S2468-1253(21)00299-5. Epub 2021 Nov 2.
citation: Jiang Y, Jarr K, Layton C, Gardner CD, Ashouri JF, Abreu MT, Sinha SR. Therapeutic Implications of Diet in Inflammatory Bowel Disease and Related Immune-Mediated Inflammatory Diseases. Nutrients. 2021 Mar 10;13(3):890. doi: 10.3390/nu13030890.