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Clinical Trials/NCT05714189
NCT05714189
Completed
N/A

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

Amsterdam UMC, location VUmc1 site in 1 country62 target enrollmentApril 1, 2021
ConditionsEndometriosis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Amsterdam UMC, location VUmc
Enrollment
62
Locations
1
Primary Endpoint
pain scores
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Amsterdam UMC, location VUmc
Responsible Party
Principal Investigator
Principal Investigator

Prof. Velja Mijatovic

Professor Doctor

Amsterdam UMC, location VUmc

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.

Outcomes

Primary Outcomes

pain scores

Time Frame: 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 Outcomes

  • Gastro-Intestinal Health(6 months)
  • Adhesion to dietary intervention(6 months)
  • Quality of Life (QoL)(6 months)

Study Sites (1)

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