Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease

NCT05683730 | Recruiting

• 1 other identifier: 2022-A02169-34
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

intermittent caloric restriction; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• Intestinal inflammation

  Evaluate the effectiveness of personalized nutritional management of intermittent caloric restriction during 16 weeks on the level of intestinal inflammation (induction of of a biological response) in patients with mild to moderate CD mild to moderate. The effectiveness will be evaluated in each group by a biological response change, that is to say a decrease at least 50% of calprotectin fecal level.

  week 16

Secondary Outcomes (13)

• Induction of a clinical response

  week 16

• Induction of a clinical remission

  week 16

• Induction of a biological remission

  week 16

• Induction of a radiological response

  week 16

• Improving quality of life

  week 16

Study Arms (2)

Intermittent caloric restriction

EXPERIMENTAL

Intermittent caloric restriction during 16 weeks.

Other: Intermittent caloric restriction

Routine practice

NO INTERVENTION

Routine practice

Interventions

Intermittent caloric restriction OTHER

Intermittente caloric restriction: 1. st month: restriction of 50% of the caloric intake previously determined by the dietician 1 day per week 2. nd month: restriction of 50% of the caloric intake 2 days per week 3. rd month: restriction of 60% of the caloric intake 2 days per week 4. th month: restriction of 75% of the caloric intake 2 days per week

Intermittent caloric restriction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU of Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, 54511, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 34739863 BACKGROUND

• 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.

  PMID: 33801883 BACKGROUND

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• CARON Bénédicte, MD

  CHRU of Nancy, Hepatogastroenterology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CARON Bénédicte, MD

CONTACT

0383155580; b.caron@chru-nancy.fr

Ludivine ODOUL, CPM

CONTACT

0383155580; l.odoul@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 13, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

FR (1)