Back to resultsThe Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
FODMAP diet
Sponsored by
About this trial
This is an interventional supportive care trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Fulfillment of the Rome III criteria for IBS.
- Aged 18-77 years at the time of screening.
- Provision of written informed consent.
- Commitment of availability throughout the 10 week study period.
- Availability of at least one GI imaging study during the last 5 years (colonoscopy, sigmoidosopy, abdominal ultrasonography, barium enema) for subjects older than 50 years.
Exclusion Criteria:
- Major abdominal surgery in the past.
- The presence of any active (organic) GI disease.
- Past or present major medical or psychiatric illness.
- Any concomitant disease.
- Alarming symptoms (rectal bleeding, weight loss, etc.)
- Pregnancy.
- Family history of colorectal carcinoma or IBD, under the age of 50.
- Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.
- Non-adjusted diet in the case of lactose or gluten intolerance.
- Recent travel to regions with endemic parasitic diseases.
Sites / Locations
- Clinical Nutrition Unit, Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
FODMAP diet
Arm Description
participants will be put on a low FODMAP diet.
Outcomes
Primary Outcome Measures
Irritable Bowel Syndrome (IBS) severity score
IBS quality of life score
Secondary Outcome Measures
Full Information
NCT ID
NCT02327780
First Posted
December 24, 2014
Last Updated
December 29, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02327780
Brief Title
The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
Official Title
The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
5. Study Description
Brief Summary
Treatment of IBS is very problematic. Despite the wide range of pharmacological and non-pharmacological therapies, there is no universally accepted approach. In recent years, the low FODMAP diet has been developed, a dietary approach that aims to relieve the symptoms of IBS. FODMAPs (Fermentable Oligosaccharides, Di-saccharides, Mono-saccharides and Polyols) are a group of dietary sugars that may be poorly absorbed in the small intestine and fermented by bacteria to produce gas. Ingestion of FODMAPs may also result in alterations in fluid content in the colon and trigger functional gut symptoms in some individuals. This study aims to examine the effectiveness of the FODMAP diet in Israel in improving symptoms of IBS compared to the standard dietary advice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FODMAP diet
Arm Type
Other
Arm Description
participants will be put on a low FODMAP diet.
Intervention Type
Other
Intervention Name(s)
FODMAP diet
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome (IBS) severity score
Time Frame
9 weeks
Title
IBS quality of life score
Time Frame
9 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fulfillment of the Rome III criteria for IBS.
Aged 18-77 years at the time of screening.
Provision of written informed consent.
Commitment of availability throughout the 10 week study period.
Availability of at least one GI imaging study during the last 5 years (colonoscopy, sigmoidosopy, abdominal ultrasonography, barium enema) for subjects older than 50 years.
Exclusion Criteria:
Major abdominal surgery in the past.
The presence of any active (organic) GI disease.
Past or present major medical or psychiatric illness.
Any concomitant disease.
Alarming symptoms (rectal bleeding, weight loss, etc.)
Pregnancy.
Family history of colorectal carcinoma or IBD, under the age of 50.
Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood count), abnormal thyroid function.
Non-adjusted diet in the case of lactose or gluten intolerance.
Recent travel to regions with endemic parasitic diseases.
Facility Information:
Facility Name
Clinical Nutrition Unit, Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
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