Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Not applicable · Testing Intermittent caloric restriction · 1 site · Central Hospital, Nancy, France
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Intermittent caloric restriction. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 4 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 174 participants are expected to take part.
- Start date: 2023-04-18.
- Main results expected around 2026-07-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Intestinal inflammation (week 16)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Central Hospital, Nancy, France |
| Enrollment | 174 (estimated) |
| Start date | 2023-04-18 |
| Primary completion (est.) | 2026-07-01 |
| First posted | 2023-01-13 |
| Last updated | 2023-06-08 |
| Official title | Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease: A Randomized, Open-label, Controlled Trial |
| ClinicalTrials.gov ID | NCT05683730 |
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
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU of Nancy | Vandœuvre-lès-Nancy, CHRU de Nancy | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.