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

Primary Purpose

Endometriosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Low FODMAP diet
Endometriosis diet
Sponsored by
Amsterdam UMC, location VUmc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Endometriosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Amsterdam AMC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

Intervention group: adherence to Low FODMAP diet

Intervention group: adherence to endometriosis diet

Control group: no diet adherence

Arm Description

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.

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.

Women were asked to complete three questionnaires, once every two months. These contained the EHP-30 and GIQLI. The first questionnaire contained questions on their demographics, and whether they applied a diet before.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
January 26, 2023
Last Updated
February 9, 2023
Sponsor
Amsterdam UMC, location VUmc
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1. Study Identification

Unique Protocol Identification Number
NCT05714189
Brief Title
The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis
Acronym
Dieetstudie
Official Title
The Effect of Dietary Interventions, or no Intervention, on Pain and Quality of Life in Women Diagnosed With Endometriosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Women could chose to adhere to a diet or the control group. there was no cross-over.
Masking
None (Open Label)
Masking Description
Women were able to choose themselves whether to adhere to a diet, and to which diet, or to adhere to the control group.
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group: adherence to Low FODMAP diet
Arm Type
Other
Arm Description
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.
Arm Title
Intervention group: adherence to endometriosis diet
Arm Type
Other
Arm Description
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.
Arm Title
Control group: no diet adherence
Arm Type
No Intervention
Arm Description
Women were asked to complete three questionnaires, once every two months. These contained the EHP-30 and GIQLI. The first questionnaire contained questions on their demographics, and whether they applied a diet before.
Intervention Type
Other
Intervention Name(s)
Low FODMAP diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Endometriosis diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain scores
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life (QoL)
Description
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.
Time Frame
6 months
Title
Gastro-Intestinal Health
Description
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.
Time Frame
6 months
Title
Adhesion to dietary intervention
Description
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
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women diagnosed with endometriosis
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Amsterdam AMC
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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