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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
174
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
CHRU of Nancy
Vandœuvre-lès-Nancy, CHRU de Nancy, France
RECRUITINGIntestinal 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.
Time frame: week 16
Induction of a clinical response
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on Crohn's Disease Activity Index (CDAI) that is to say change by al least 100 points. The following cut-offs correlate with level of disease activity: Non-active disease: CDAI \< 150 Mild disease activity: CDAI \>= 150 and \<220 Moderate disease activity: CDAI \>= 220 and \<450 Severe disease activity: CDAI \> 450
Time frame: week 16
Induction of a clinical remission
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on clinical remission, that is to say Crohn's Disease Activity Index (CDAI) \< 150 The following cut-offs correlate with level of disease activity: Non-active disease: CDAI \< 150 Mild disease activity: CDAI \>= 150 and \<220 Moderate disease activity: CDAI \>= 220 and \<450 Severe disease activity: CDAI \> 450
Time frame: week 16
Induction of a biological remission
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on biological remission that is to say fecal calprotection \< 250 µg/g
Time frame: week 16
Induction of a radiological response
Evaluate the impact of personalized nutritional management of intermittent caloric restriction during 16 weeks on radiological response that is to say change of 50% of Nancy score measured by magnetic resonance imaging (MRI) Total MRI score: 0 at 36
Time frame: week 16
Improving quality of life
Evaluated by short-Inflammatory Bowel Disease Questionnaire (short-IBDQ) short-IBDQ is a 10-items measure that assesses self-reported quality of life. Total score ranges from 10 to 70. Higher the score is better life quality is.
Time frame: week 16
Improving work productivity
Evaluated by Work Productivity and Activity Impairment Questionnaire (WPAI) WPAI questions measure the effect of patients health problems (any physical or emotional problem or symptom) on their ability to work and perform regular activites.
Time frame: week 16
Improving fatigue
Evaluated by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) FACIT-F is a 40-items measure that assesses self-reported fatigue and its impact upon daily activities and function.
Time frame: week 16
Improving functional disability
Evaluated by Inflammatory Bowel Disease - Disability Index (IBD-DI) IBD-DI is a 14-items measure that assesses self-reported disability. It ranges from 0-100: 0-20 (no disability), 20-35 (mild disability), 35-50 (moderate disability) and 50-100 (severe disability)
Time frame: week 16
Improving anxiety disorder
Evaluated by Generalized Anxiety Disorder (GAD-7) The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Time frame: week 16
Evaluate the safety of intermittent caloric restriction in patients with mild to moderate with mild to moderate CD.
Percentage of adverse event related to intermittent caloric restriction (fatigue; nausea; headache, dizziness, hypotension, irritability, capacity reduced to concentrating, undernutrition/sarcopenia)
Time frame: weeks 4;8;12 and 16
Evaluate compliance of intermittent caloric restriction during 16 weeks in patients with with mild to moderate CD.
Percentage of patient compliance measured by for example a intermittent caloric restriction during at least 21 days on the 16 weeks of the study
Time frame: week 16
Determine the level of patient satisfaction with intermittent caloric restriction
Evaluated by Likert scale at 4 items ad-hoc 4 point likert scale for the frequency; assign each response a point value from 1 to 4.
Time frame: week 16
Estimate, in the experimental arm, the prevalence of compensatory hyperphagia after intermittent caloric restriction
Percentage of patients having a compensatory hyperphagia after 2 days of intermittent caloric restriction.
Time frame: 48 hours after intermittent caloric restriction
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