Pain in Endometriosis And the Relation to Lifestyle

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age17+
SponsorRadboud University Medical Center

About this trial

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).

Eligibility criteria

Qualifiers

Confirmed diagnosis of endometriosis via ultrasound, MRI or surgery*

NRS pain score > 4*

Age from 17 years

Premenopausal status

Disqualifiers

Recurrent miscarriages (> 2)

Eating disorder

Diagnosed with Crohn's disease, Ulcerative Colitis, short bowel syndrome or another chronic inflammatory disease

Self-reported celiac disease

Trial design

Treatments tested in this trial

  • Anti-inflammatory diet (DI)
  • Cognitive behavioral therapy (CBT)

Treatment groups

250 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Radboud University Medical Center

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Belgian Volition SRL

Collaborator

ASSOCIATION OF PEOPLE WITH ENDOMETRIOSIS I AM 1 IN 10

Collaborator

Wageningen University and Research

Collaborator

Endometriosis UK

Collaborator

University College Cork

Collaborator

SVEUCILISTE U ZAGREBU MEDICINSKI FAKULTET

Collaborator

UNIWERSYTET MEDYCZNY W LUBLINIE

Collaborator

University of Edinburgh

Collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborator

Université Catholique de Louvain

Collaborator

University of Bonn

Collaborator

Biopsychology

Collaborator

Horizon Europe

Collaborator