Clinical trial NCT02825316: Mediterranean Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
Official title: Mediterranean Diet vs. Low Residue Diet as an add-on Therapy for Induction of Remission in Patients With Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn's Disease
Keywords: Crohn's disease
inflammatory bowel diseases
Mediterranean diet
microbiome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is designed to evaluate the effect of Mediterranean diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.

Detailed description: The Mediterranean diet has been associated with anti-inflammatory properties and with decreased risk for several chronic diseases. However, the effect of Mediterranean diet has not been evaluated in patients with inflammatory bowel diseases.

The purpose of this study is to determine whether Mediterranean diet is superior to a low residue diet as an add-on therapy for induction of remission in adult patients with active Crohn's disease and to evaluate its effects on clinical, inflammatory and microbial parameters.

Seventy eligible patients will be randomly assigned to one of two dietary interventions: Mediterranean diet or low residue diet, as an add-on therapy for induction of remission of active Crohn's disease. The effect of the dietary regimens on clinical, inflammatory and microbial parameters will be assessed at 8 and 52 weeks.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age: 18-75
* Diagnosis of Crohn's Disease
* Montreal classification- B1
* CDAI: 150-450 + CRP\>0.5 or fecal calprotectin \>200
* Induction therapy with corticosteroids, 5-ASA, AZA, 6-MP, MTX or biologic therapy
* Capacity to give informed consent

Exclusion Criteria:

* Ileostomy or colostomy
* Exclusive enteral nutrition/ partial enteral nutrition
* History of or current severe systemic diseases
* History of admission due to bowel obstruction
* Positive Clostridium difficile toxin
* Positive Salmonella, Shigella, Campylobacter, stool culture
* Pregnancy or lactation
* Use of antibiotics or steroids one month prior to inclusion

Primary outcomes:
measure: Crohn's Disease Activity Index (CDAI)
timeFrame: 8 weeks
Secondary outcomes:
measure: C-reactive protein
timeFrame: 8 weeks
measure: Fecal calprotectin
timeFrame: 8 weeks
measure: Remission rate- CDAI<150 + normal CRP/ fecal calprotectin
timeFrame: 52 weeks
measure: Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin
timeFrame: 8 weeks
measure: Microbial composition
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Head, IBD Center, Department of Gastroenterology and Liver Diseases Tel Aviv Sourasky Medical Center
name: Iris Dotan, MD
role: PRINCIPAL_INVESTIGATOR
References: