Pain in Endometriosis And the Relation to Lifestyle

Last updated: December 6, 2024
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysfunctional Uterine Bleeding

Endometriosis

Treatment

Anti-inflammatory diet (DI)

Cognitive behavioral therapy (CBT)

Clinical Study ID

NCT06332560
NL86247.091.24
  • Ages > 17
  • Female

Study Summary

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.

Participants will be randomized between standard care (control group), standard care and an anti-inflammatory diet, or standard care, anti-inflammatory diet and cognitive behavioral therapy or CBT alone.

Participants will follow an anti-inflammatory diet based on the Dutch Dietary Guidelines or CBT or a combination of both interventions for 12 weeks. They will receive personalized dietary advice from a dietician and recipes will be available. cognitive behavioral therapy will be administered in a total of seven individual sessions led by a psychotherapist. The content of these sessions will be psycho-education regarding pain mechanisms and diet.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 weeksfrom hormonal contraception (if applicable) during the study period.

Exclusion

Exclusion Criteria:

  • Recurrent miscarriages (> 2)

  • Eating disorder

  • Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or anotherchronic 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

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Anti-inflammatory diet (DI)
Phase:
Study Start date:
October 04, 2024
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • Jeroen Bosch Hospital (JBZ)

    's-Hertogenbosch,
    Netherlands

    Active - Recruiting

  • Rijnstate Hospital

    Arnhem,
    Netherlands

    Active - Recruiting

  • Amphia

    Breda,
    Netherlands

    Active - Recruiting

  • Catharina Hospital

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Radboud University Medical Center

    Nijmegen,
    Netherlands

    Active - Recruiting

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