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

Endometriosis Clinical Trial

— Dieetstudie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05714189
• Other study ID #: W20_534 # 20.593
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• Low FODMAP diet
The Low FODMAP diet is an avoidance diet and consist of three phases. In the first phase, all nutrients high in FODMAPs (high-FODMAPS) are eliminated from the daily diet over a period of 2 to 6 weeks to calm down the bowel. The second phase consists of the addition of FODMAP challenges. During this phase the patient continues the Low FODMAP diet, but will reintroduce one high-FODMAP nutrient once every three days to see whether exposure to this high-FODMAP causes IBS symptoms. When this is not the case, the patient can continue eating this high-FODMAP group in their daily diet. In the third and final phase, the diet is fully personalized. This personalization is based on whether the patient tolerated the high-FODMAP nutrient or not during the FODMAP challenges. Only when the high-FODMAP nutrient is not tolerated, it is advised to permanently remove it from the daily diet.
• Endometriosis diet
The endometriosis diet The endometriosis diet is a patient experience based, avoidance diet developed by women diagnosed with endometriosis. Therefore no specific recommendations exist regarding the application of the endometriosis diet. With the endometriosis diet, women avoid nutrients they noticed provoked or aggravated their endometriosis-related symptoms such as red meat, coffee, sugar, lactose and soy.

Locations

Country	Name	City	State
Netherlands	Amsterdam AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain scores	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.	6 months
Secondary	Quality of Life (QoL)	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.	6 months
Secondary	Gastro-Intestinal Health	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.	6 months
Secondary	Adhesion to dietary intervention	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	6 months