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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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12 December 2020 |
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Main ID: |
NCT03492333 |
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Date of registration:
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03/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status
GFD_IBS |
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Scientific title:
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The Role of Antigliadin Antibodies in Predicting the Beneficial Effect of Gluten Free Diet in Unselected IBS Patients |
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Date of first enrolment:
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April 30, 2012 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03492333 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Premysl Bercik, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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McMaster University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients
- IBS diagnosis (Rome III)
- Willingness to participate
Exclusion Criteria:
- history of any organic disease including celiac disease
- Immune deficiency
- Major abdominal surgery
- Use of immunosuppressants, glucocorticosteroids or opioids
- Use of antibiotics in the last 3 months
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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IBS - Irritable Bowel Syndrome
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Intervention(s)
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Other: Gluten free diet
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Primary Outcome(s)
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Improvement on gastrointestinal symptoms
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Improvement quality of life and well-being
[Time Frame: 4 weeks]
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Improvement somatization
[Time Frame: 4 weeks]
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Improvement anxiety and/or depression
[Time Frame: 4 weeks]
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Changes in gut microbiota
[Time Frame: 4 weeks]
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Normalization of gastrointestinal transit
[Time Frame: 4 weeks]
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Secondary ID(s)
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AGA_GFD_in_IBS
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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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