NCT06332560

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Oct 2024May 2027

First Submitted

Initial submission to the registry

March 13, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

October 4, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

August 11, 2025

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

March 13, 2024

Last Update Submit

August 5, 2025

Conditions

EndometriosisAdenomyosis

Keywords

endometriosispainquality of lifeimmunologyanti-inflammatory dietcognitive behavioral therapyadenomyosisdietmicrobiome

Outcome Measures

Primary Outcomes (1)

  • Change in Pain intensity assessed by the Numerical Rating Scale

    The Numerical Rating Scale (NRS) ranges from 0 (no pain) to 10 (unbearable pain), and is the most commonly used subjective measure to assess pain intensity. Patients will score there estimated average pain intensity and there highest pain intensity of the previous 7 days. Minimum value: 0 Maximum value: 10 Higher score indicates a higher level of pain intensity.

    3 months

Secondary Outcomes (8)

  • Change in health related quality of life assessed by the Endometriosis Health Profile 30

    3 months

  • Change in general quality of llife assessed by the Short Form 36

    3 months

  • Change in inflammatory characteristics in menstruum

    3 months

  • Change in inflammatory charecteristics in peripheral blood

    3 months

  • Change in soluble factors in plasma

    3 months

  • +3 more secondary outcomes

Other Outcomes (12)

  • Change in sleep quality assessed by the PSQI

    3 months

  • Change in physical activity level assessed by the IPAQ-SF

    3 months

  • Change in subjective stress assessed by the PSS

    3 months

  • +9 more other outcomes

Study Arms (5)

Standard care (control group)

NO INTERVENTION

Standard care and an anti-inflammatory diet (DI group)

EXPERIMENTAL
Behavioral: Anti-inflammatory diet (DI)

Standard care, anti-inflammatory diet and cognitive behavioral therapy (DI + CBT group)

EXPERIMENTAL
Behavioral: Anti-inflammatory diet (DI)Behavioral: Cognitive behavioral therapy (CBT)

Standard care and cognitive behavioral therapy (CBT group)

EXPERIMENTAL
Behavioral: Cognitive behavioral therapy (CBT)

Healthy controls

NO INTERVENTION

Healthy controls without endometriosis

Interventions

Anti-inflammatory diet (DI)BEHAVIORAL

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

Also known as: DI
Standard care and an anti-inflammatory diet (DI group)Standard care, anti-inflammatory diet and cognitive behavioral therapy (DI + CBT group)
Cognitive behavioral therapy (CBT)BEHAVIORAL

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

Also known as: CBT
Standard care and cognitive behavioral therapy (CBT group)Standard care, anti-inflammatory diet and cognitive behavioral therapy (DI + CBT group)

Eligibility Criteria

Age17 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspersons assigned female at birth
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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
  • 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.

You may not qualify 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Jeroen Bosch Hospital (JBZ)

's-Hertogenbosch, Netherlands

RECRUITING

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

Amphia

Breda, Netherlands

RECRUITING

Catharina Hospital

Eindhoven, Netherlands

RECRUITING

Radboud University Medical Center

Nijmegen, Netherlands

RECRUITING

MeSH Terms

Conditions

EndometriosisAdenomyosisPain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Emma Huijs

CONTACT

06-29698762pearl-studie.verlgyn@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 27, 2024

Study Start

October 4, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

August 11, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

NL(5)