Feasibility study: The effect of the low FODMAP diet on women suffering from endometriosis
- Conditions
- digestive problemsDysmenorrhoea10013326
- Registration Number
- NL-OMON52456
- Lead Sponsor
- Maxima Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
Subjects meeting all of the following criteria will be able to participate in
the study:
- Premenopausal women (>= 18 years old)
- Diagnosed with endometriosis by ultrasound, laparoscopy or MRI
- Experiencing abdominal symptoms such as abdominal pain, bloating, flatulence,
obstipation, diarrhoea, gurgling, urgency or nausea
Subjects meeting any of the following criteria will be excluded from
participating in the study:
- Postmenopausal or aged under 18 years old
- Women not able to speak, read or write Dutch
- Gastro-intestinal co-morbidities such as food allergy, Crohn*s disease,
Ulcerative Colitis, Coeliac disease
- Diagnosed with Diabetes Mellitus
- Currently following another diet
- Currently pregnant
- Planned for surgery during the research period
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the change in abdominal symptoms, such as constipation<br /><br>and fecal incontinence, measured using the Groningen DeFeC questionnaire, ought<br /><br>to be filled in at the start of the diet, after the elimination period and<br /><br>after the re-introduction period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome is the change in quality of life measured using the<br /><br>EHP-30 questionnaire, ought to be filled in at the start of the diet, after the<br /><br>elimination period and after the re-introduction period.</p><br>