The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis

Not Applicable

Completed

• Conditions: Endometriosis
• Interventions: Other: Low FODMAP diet; Other: Endometriosis diet

• Registration Number: NCT05714189
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet.

Detailed Description

This prospective pilot study was performed to explore the influence of a dietary intervention, the Low FODMAP diet or endometriosis diet, on endometriosis-related pain and Quality of Life (QoL). Participants could choose between adherence to a diet; the Low FODMAP diet or endometriosis diet, or to contribute to the control group and not adhere to a diet. Women choosing to adhere to a diet were extensively guided by a dietician in training. In addition, both groups are asked to complete three questionnaires over a period of six months; once every two months.

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-01-26
• Status Verified: 2023-02
• Study First Posted: 2023-02-06
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• Women diagnosed with endometriosis, either through radiologic imaging (transvaginal ultrasound and/or MRI) or laparoscopy
• A reported pain score of ≥ 3 (Visual Analogue Score (VAS), scale 0-10cm) in one or more of the following symptoms: dysmenorrhea, deep dyspareunia and chronic pelvic pain

Exclusion Criteria

• about to undergo an operation within six months
• Undergone an operation in the past six weeks
• a switch in hormonal therapy within six weeks
• Women that were pregnant or breastfeeding
• women diagnosed with a malignancy
• An additional diagnosis with Coeliac Disease (CD) and/or lactose intolerance.
• Not sufficient in the Dutch or English language.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group: adherence to Low FODMAP diet	Low FODMAP diet	Women could choose to adhere to the low FODMAP diet, over a period of six months. In the first three months, they received extensive guidance by a dietician in training, in addition to supportive materials such as the Monash app, recipes and grocery lists, in the hope of optimal adherence to the diet. After three months, women were asked to continue the diet independently. In addition, women were asked to complete three questionnaires, one every two months. The questionnaires contained the EHP-30, the GIQLI, and self composed questions on their demographics in the first questionnaire, and their strictness of adherence in the second and third questionnaire. The third questionnaire also contained questions on their satisfaction with the dietary guidance and the dietician in training.
Intervention group: adherence to endometriosis diet	Endometriosis diet	Women could choose to adhere to the endometriosis diet, over a period of six months. In the first three months, they received extensive guidance by a dietician in training, in addition to supportive materials such as the Monash app, recipes and grocery lists, in the hope of optimal adherence to the diet. After three months, women were asked to continue the diet independently. In addition, women were asked to complete three questionnaires, one every two months. The questionnaires contained the EHP-30, the GIQLI, and self composed questions on their demographics in the first questionnaire, and their strictness of adherence in the second and third questionnaire. The third questionnaire also contained questions on their satisfaction with the dietary guidance and the dietician in training.

Primary Outcome Measures

Name	Time	Method
pain scores	6 months	The primary outcome focused on pain scores (in VAS, scale 0-10cm) of the endometriosis-related symptoms dysmenorrhea, deep dyspareunia, chronic pelvic pain, dysuria, dyschezia, tiredness and bloating. Pain scores will be measured on a scale between 0 and 10, where 0 represents no pain at all and 10 the worst pain possible.

Secondary Outcome Measures

Name	Time	Method
Gastro-Intestinal Health	6 months	Secondary outcome focused on gastro-intestinal health, expressed using the GIQLI questionnaire. With the GIQLI, a score between 0 and 144 can be calculated where 0 represents worst possible gastro-intestinal health and 144 best possible gastro-intestinal health.
Adhesion to dietary intervention	6 months	with every follow-up visit, women were asked on their dietary adhesion. they were asked how often they made an exception, with what meal (snack/main meal) and what strictness score they gave themselves. Women could score their strictness between 0 and 10 where 0 represented worst possible strictness and 10 best possible strictness
Quality of Life (QoL)	6 months	Secondary outcome focused on QoL, expressed using the EHP-30 questionnaire. Using the EHP-30, a score between 0 and 100 can be measured for 11 different QoL domains. For every domain, a score of 0 represents best health status through to a score of 100 which represents worst health status.

Trial Locations

Locations (1)

Amsterdam AMC; 🇳🇱 Amsterdam, Netherlands