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
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