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ID
Source
Brief title
Health condition
Endometriosis, low FODMAP diet
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the change in abdominal symptoms measured using the Groningen DeFeC questionnaire.
Secondary outcome
The secondary outcome is the change in quality of life measured using the EHP-30 questionnaire
Background summary
Endometriosis is a benign gynaecological condition defined as the presence of endometrial tissue outside of the uterus with a prevalence of 7-10% within the general population of premenopausal women. Frequent symptoms include chronic inflammation, abdominal pain, dysmenorrhoea and subfertility. 15-22% of the women also present bowel symptoms such as a bloated feeling and changing stool, comparable to the symptoms experienced with irritable bowel syndrome (IBS). Visceral hypersensitivity is a factor that seems to play a role in both endometriosis as IBS. A curative therapy for endometriosis has not been found yet and therefore research into optional therapies focused on symptom control is of great value, with visceral hypersensitivity as a logical target for intervention. A known visceral hypersensitivity targeted therapy for IBS with significant reduction of abdominal symptoms is the low FODMAP diet. FODMAP is an abbreviation of Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols, short-chain carbohydrates found in numerous fruits, vegetables and grains. During the diet the poorly absorbed carbohydrates are eliminated, that otherwise cause an increase in small intestinal water volume and colonic gas production. Doing so, the exacerbation of gastro-intestinal symptoms will reduce and intestinal luminal distension causing abdominal pain and a bloated feeling should be prevented, especially in those with visceral hypersensitivity. Recent literature found a significant reduction in symptoms in women suffering from both endometriosis and IBS after introducing the low FODMAP diet. The common symptoms between endometriosis and IBS suggest that this diet could be a therapy for women only suffering from endometriosis as well.
This study aims to evaluate the effect of the low FODMAP diet on the symptoms of patients with endometriosis.
The primary outcome is the change in abdominal symptoms measured using the Groningen DeFeC questionnaire. The secondary outcome is the change in quality of life measured using the EHP-30 questionnaire. Both questionnaires are to be filled in at the start of the diet, after the elimination period and after the re-introduction period.
Study objective
The hypothesis is that women suffering from endometriosis will benefit from the low FODMAP diet with a significant improvement in their symptoms related to visceral hypersensitivity.
Study design
- At the start of the low FODMAP diet
- After the elimination period (approximately 4 weeks)
- After the re-introduction period (approximately 6 weeks)
Intervention
The low FODMAP diet
Inclusion criteria
Subjects meeting all of the following criteria will be able to participate in the study:
- Premenopausal women (≥ 18 years old)
- Diagnosed with endometriosis by anamnesis, ultrasound, laparoscopy or MRI
- Experiencing abdominal symptoms such as abdominal pain, bloating, flatulence, obstipation, diarrhoea, gurgling, urgency or nausea
- Been prescribed the low FODMAP diet
Exclusion criteria
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
- Currently pregnant
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8022 |
| CCMO | NL71354.015.19 |
| OMON | NL-OMON52456 |