Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome
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ClinicalTrials.gov Identifier: NCT02924493 |
Recruitment Status :
Completed
First Posted : October 5, 2016
Last Update Posted : May 17, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | September 15, 2016 | ||||
First Posted Date ICMJE | October 5, 2016 | ||||
Last Update Posted Date | May 17, 2018 | ||||
Actual Study Start Date ICMJE | July 3, 2017 | ||||
Actual Primary Completion Date | December 1, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome | ||||
Official Title ICMJE | Dietary Treatment of Endometriosis-related Irritable Bowel Syndrome: A Pilot Study | ||||
Brief Summary | Many patients with endometriosis experience extra genital and abdominal symptoms as a major part of their problem. This includes gastrointestinal dysfunction with pain, urinary symptoms compatible with interstitial cystitis and gastrointestinal symptoms resembling the irritable bowel syndrome (IBS). Such problems may be secondary to changes in autonomous neuronal structure and function elicited by the endometriotic elements, which may cause a "visceral syndrome" with the above mentioned symptoms. The investigators hypothesize that dietary treatment will improve the experience of gastrointestinal symptoms, pain and quality of life in patients with endometriosis-related irritable bowel syndrome. The aim of this first randomized, placebo controlled pilot study investigating patients with both endometriosis and IBS, is to test the application of a low FODMAP diet and a placebo diet for endometriosis-related IBS-like symptoms in order to stablish a platform for a randomized controlled study. Thus, the primary aim of this pilot study is to investigate the applicability of a placebo diet in patients with endometriosis and to investigate the compliance in both intervention group and control group. In addition, the aim is to investigate whether the participants find the diet manageable and whether they are able to identify the placebo diet. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Other: Diet low in fermentable carbohydrates (low FODMAP diet)
The participants follow the diet in 4 weeks. They have been provided with some foods (bread, pasta, cereal products), but will by the rest themselves. They have been provided with lists of foods to include and foods to avoid. They have also been provided with suggestions to a 4 week meal plan, based in their individual need for energy.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
22 | ||||
Original Estimated Enrollment ICMJE |
24 | ||||
Actual Study Completion Date ICMJE | February 1, 2018 | ||||
Actual Primary Completion Date | December 1, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Denmark | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02924493 | ||||
Other Study ID Numbers ICMJE | Diet-in-endometriosis | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | University of Aarhus | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Aarhus | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | University of Aarhus | ||||
Verification Date | October 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |