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New treatment option for Endometriosis
Official title Pain in Endometriosis And the Relation to Lifestyle
ClinicalTrials.gov ID: NCT06332560
What this study is testing
- What it's testing
- The goal of this clinical trial is to investigate the effect of an anti-inflammatory diet and cognitive behavioral therapy (CBT) on pain symptoms, health related quality of life and the effect on inflammatory characteristics in serum and menstruum samples as well as the effect on the gut and vaginal microbiome in women with endometriosis. In addition, we want to investigate the differences in stress (measured by hair cortisol levels), inflammatory markers in peripheral blood, menstrual effluent, and the vaginal and intestinal microbiome between persons without and with endometriosis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 17 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Confirmed diagnosis of endometriosis via ultrasound, MRI or surgery\
- NRS pain score \> 4\
- Age from 17 years
- Premenopausal status
- Body Mass Index (BMI) 18-30 kg/m2
You likely can't join if
- Recurrent miscarriages (\> 2)
- Eating disorder
- Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease
- Self-reported celiac disease
- Vegan diet
- Smoking
See the full eligibility criteria
- Confirmed diagnosis of endometriosis via ultrasound, MRI or surgery\
- NRS pain score \> 4\
- Age from 17 years
- Premenopausal status
- Body Mass Index (BMI) 18-30 kg/m2
- Ability to understand the explanation about the diet intervention (DI) and CBT\
- Willing to follow the DI\
- Willing to continue their use of food supplements
- Willing to undergo CBT\
- Willing to collect menstrual effluent, and therefore willing to have two stop weeks from hormonal contraception (if applicable) during the study period.
- Recurrent miscarriages (\> 2)
- Eating disorder
- Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease
- Self-reported celiac disease
- Vegan diet
- Smoking
- Use of immunosuppressive or psychotropic medication
- Score on FFQ \> 120
- Diagnosed with severe mental disorder currently requiring treatment by psychiatrist
- NRS average score below 4 during the last month
- Participation in another intervention study
- Unable to speak Dutch or to understand the intervention
- Need for surgery during the participation in the study
- Serious pain (NRS \> 4) from other origin than endometriosis
- Pregnant
- Scalp hair shorter than 4 cm
- Only applicable to patients with endometriosis
The study team makes the final eligibility decision.
Where it's taking place
- 's-Hertogenbosch, Netherlands
- Arnhem, Netherlands
- Breda, Netherlands
- Eindhoven, Netherlands
- Nijmegen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 17 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 's-Hertogenbosch, Netherlands; Arnhem, Netherlands; Breda, Netherlands; Eindhoven, Netherlands; Nijmegen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.