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

NCT ID: NCT05683730

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2027-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intermittent caloric restriction

Intermittent caloric restriction during 16 weeks.

Group Type: EXPERIMENTAL

Intermittent caloric restriction

Intervention Type: 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

Routine practice

Routine practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intermittent caloric restriction

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

CARON Bénédicte

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CARON Bénédicte, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU of Nancy, Hepatogastroenterology Department

Locations

CHRU of Nancy

Vandœuvre-lès-Nancy, CHRU de Nancy, France

Site Status: RECRUITING

Countries

France

Central Contacts

CARON Bénédicte, MD

Role: CONTACT

b.caron@chru-nancy.fr

0383155580

Ludivine ODOUL, CPM

Role: CONTACT

l.odoul@chru-nancy.fr

0383155580

Facility Contacts

CARON Bénédicte, MD

Role: primary

b.caron@chru-nancy.fr

0383155580

LUDIVINE ODOUL

Role: backup

l.odoul@chru-nancy.fr

0383155580

References

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.

Reference Type: BACKGROUND

PMID: 34739863 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33801883 (View on PubMed)

Other Identifiers

2022-A02169-34

Identifier Type: -

Identifier Source: org_study_id