Pain in Endometriosis And the Relation to Lifestyle

Официальное название

Pain in Endometriosis And the Relation to Lifestyle: Effectiveness of a Dietary Intervention and Cognitive Behavioral Therapy in Endometriosis-associated Pain

Обзор

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).

Вмешательства

• Поведенческое Anti-inflammatory diet (DI)
  12-week personalized dietary advice based on the Dutch Dietary Guidelines under the guidance of a dietician.
• Поведенческое 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.

Первичные конечные точки

• Change in Pain intensity assessed by the Numerical Rating Scale [Срок оценки: 3 months]

Вторичные конечные точки (8)

• Change in health related quality of life assessed by the Endometriosis Health Profile 30 [Срок оценки: 3 months]
• Change in general quality of llife assessed by the Short Form 36 [Срок оценки: 3 months]
• Change in inflammatory characteristics in menstruum [Срок оценки: 3 months]
• Change in inflammatory charecteristics in peripheral blood [Срок оценки: 3 months]
• Change in soluble factors in plasma [Срок оценки: 3 months]
• Change in the composition of vaginal and intestinal microbiome [Срок оценки: 3 months]
• Change in objective stress assessed by measuring scalp hair cortisol levels [Срок оценки: 3 months]
• Adherence and anti-inflammatory status of the diet [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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
• Scalp hair shorter than 4 cm

• Only applicable to patients with endometriosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Нидерланды · 5 центров

• Jeroen Bosch Hospital (JBZ) — 's-Hertogenbosch
• Rijnstate Hospital — Arnhem
• Amphia — Breda
• Catharina Hospital — Eindhoven
• Radboud University Medical Center — Nijmegen

Публикации

• Huijs E, van der Sman L, Wirken L, Delcliseur HS, Winter EG, de Roos NM, van der Molen RG, Oosterman JM, Vigano P, Horne AW, Dolmans MM, Hoogstad-van Evert JS, Nap AW; EUmetriosis Working Group. Effectiveness of an anti-inflammatory diet intervention and cognitive behavioural therapy in endometriosis: protocol for a randomised controlled clinical trial. BMJ Open. 2026 May 26;16(5):e116964. doi: 10 PMID 42191188

Идентификаторы

NCT: NCT06332560 · NL86247.091.24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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