Pain in Endometriosis And the Relation to Lifestyle

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

Conditions

• Endometriosis
• Adenomyosis

Interventions

BEHAVIORAL

Anti-inflammatory diet (DI)

12-week personalized dietary advice based on the Dutch Dietary Guidelines under the guidance of a dietician.

BEHAVIORAL

Cognitive behavioral therapy (CBT)

Seven individual sessions led by a psychotherapist. The content of the CBT will be psycho-education regarding pain mechanisms and DI.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Belgian Volition SRL

  collaborator UNKNOWN

• ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10

  collaborator UNKNOWN

• Wageningen University and Research

  collaborator OTHER

• Endometriosis UK

  collaborator UNKNOWN

• University College Cork

  collaborator OTHER

• SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET

  collaborator UNKNOWN

• UNIWERSYTET MEDYCZNY W LUBLINIE

  collaborator UNKNOWN

• University of Edinburgh

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Université Catholique de Louvain

  collaborator OTHER

• University Bonn

  collaborator UNKNOWN

• Biopsychology

  collaborator UNKNOWN

• Horizon Europe

  collaborator UNKNOWN

• Radboud University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

17 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-04

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Netherlands

Study Locations