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

Amsterdam UMC, location VUmc

Status: Completed

Conditions: Endometriosis

Treatments: Other: Endometriosis diet; Other: Low FODMAP diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05714189

W20_534 # 20.593

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Intervention group: adherence to Low FODMAP diet

Other group

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.

Treatment:

Other: Low FODMAP diet

Intervention group: adherence to endometriosis diet

Other group

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.

Treatment:

Other: Endometriosis diet

Control group: no diet adherence

No Intervention group

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.