The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
Primary Purpose
Inflammatory Bowel Diseases, Crohn's Disease, Dietary Modification
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Mediterranean diet
Specific Carbohydrate Diet
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18-75;
- Able and willing to sign an informed consent;
- Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.
Exclusion Criteria:
- Patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, significant comorbidity that precludes the patient from participating according to the physicians' judgment, non-Hebrew readers, pregnant and lactating women.
Sites / Locations
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet
Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet
Outcomes
Primary Outcome Measures
Microbial diversity
Shannon α-diversity index
Secondary Outcome Measures
Clinical score
Pouchitis Disease Activity Index (PDAI)
C-reactive protein (CRP)
Inflammatory marker
fecal calprotectin
Inflammatory marker
Quality of life
Inflammatory bowel diseases questionnaire (IBDQ)
Microbial composition
Change in the abundance of microbial taxa
Full Information
NCT ID
NCT02858557
First Posted
July 28, 2016
Last Updated
August 5, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02858557
Brief Title
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
Official Title
The Effect of the Mediterranean Diet and the Specific Carbohydrate Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical study is designed to evaluate the effect of two dietary patterns, Mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.
Detailed Description
Increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory bowel diseases. One possible mechanism for the effect of diet on intestinal inflammation is modification of the gut microbial composition. However, the relationship between diet, the microbiome and intestinal inflammation is still vague.
The investigators plan to perform a crossover clinical trial. Seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the Mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. Based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn's Disease, Dietary Modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Patients will be allocated to 7 days of Mediterranean diet and then will cross over to 7 days of specific carbohydrate diet
Arm Title
Group B
Arm Type
Experimental
Arm Description
Patients will be allocated to 7 days of specific carbohydrate diet and then will cross over to 7 days of Mediterranean diet
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean diet
Intervention Description
The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats.
Intervention Type
Behavioral
Intervention Name(s)
Specific Carbohydrate Diet
Intervention Description
The specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides.
Primary Outcome Measure Information:
Title
Microbial diversity
Description
Shannon α-diversity index
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Clinical score
Description
Pouchitis Disease Activity Index (PDAI)
Time Frame
7 days
Title
C-reactive protein (CRP)
Description
Inflammatory marker
Time Frame
7 days
Title
fecal calprotectin
Description
Inflammatory marker
Time Frame
7 days
Title
Quality of life
Description
Inflammatory bowel diseases questionnaire (IBDQ)
Time Frame
7 days
Title
Microbial composition
Description
Change in the abundance of microbial taxa
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-75;
Able and willing to sign an informed consent;
Underwent pouch surgery because of refractory UC or Familial Adenomatous Polyposis (FAP) and have a functioning pouch.
Exclusion Criteria:
Patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, significant comorbidity that precludes the patient from participating according to the physicians' judgment, non-Hebrew readers, pregnant and lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lihi Godny, B.Sc
Phone
+9723947305
Email
lihig@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Dotan, MD
Organizational Affiliation
Head, IBD center, Department of gastroenterology and liver diseases, Tel Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
We'll reach out to this number within 24 hrs