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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02327780 |
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Date of registration:
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24/12/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome
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Scientific title:
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The Effectivness of FODMAP Diet in Israel in Relieving Symptoms of Patients With Irritable Bowel Syndrome |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02327780 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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Israel
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Fulfillment of the Rome III criteria for IBS.
2. Aged 18-77 years at the time of screening.
3. Provision of written informed consent.
4. Commitment of availability throughout the 10 week study period.
5. 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:
1. Major abdominal surgery in the past.
2. The presence of any active (organic) GI disease.
3. Past or present major medical or psychiatric illness.
4. Any concomitant disease.
5. Alarming symptoms (rectal bleeding, weight loss, etc.)
6. Pregnancy.
7. Family history of colorectal carcinoma or IBD, under the age of 50.
8. Abnormal laboratory studies (blood biochemistry, liver enzymes, complete blood
count), abnormal thyroid function.
9. Non-adjusted diet in the case of lactose or gluten intolerance.
10. Recent travel to regions with endemic parasitic diseases.
Age minimum:
18 Years
Age maximum:
77 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome
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Intervention(s)
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Other: FODMAP diet
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Primary Outcome(s)
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IBS quality of life score
[Time Frame: 9 weeks]
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Irritable Bowel Syndrome (IBS) severity score
[Time Frame: 9 weeks]
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Secondary ID(s)
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407-14-TLV
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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