Crohn's Disease
Conditions
Keywords
Crohn's disease, inflammatory bowel diseases, Mediterranean diet, microbiome
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.
Interventions
BEHAVIORALMediterranean diet
Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
BEHAVIORALLow residue diet
Eight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains).
Sponsors
michal roll
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crohn's Disease Activity Index (CDAI) | 8 weeks | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein | 8 weeks | Change from baseline |
| Fecal calprotectin | 8 weeks | Change from baseline |
| Remission rate- CDAI<150 + normal CRP/ fecal calprotectin | 52 weeks | — |
| Response rate- decrease in 70 points in CDAI + decreased CRP/ fecal calprotectin | 8 weeks | — |
| Microbial composition | 8 weeks | — |
Contacts
Primary ContactLihi Godny, B.Sc
Outcome results
None listed