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Идёт набор NCT07168499

Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis

Без фазы С лечением IBD (Inflammatory Bowel Disease)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Diet Management, Stress Management.
Кому может быть актуально
Состояния в реестре: IBD (Inflammatory Bowel Disease). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

D-SCAPE - Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis - A Pragmatic Clinical Trial

Обзор

Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC. Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores. Groups: 1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit. 2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes). 3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes). 4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes). All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.

Вмешательства

  • Поведенческое Diet Management
    Visit with IBD dietician for diet management specifically for IBD
  • Поведенческое Stress Management
    Visit with IBD GI psychologist for stress management

Первичные конечные точки

  • Change marked by clinical remission of IBD [Срок оценки: 12 weeks, 24 weeks]
Вторичные конечные точки (2)
  • Clinical responses [Срок оценки: 12 weeks, 24 weeks]
  • Change in patient illness perception about disease and self-reported outcomes [Срок оценки: 12 weeks, 24 weeks]

Критерии участия

Критерии включения

  • Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
  • At least 18 years of age
  • Established diagnosis of CD, UC, or IBD-unspecified
  • Recent (within 6 months) objective evidence of active IBD on colonoscopy or intestinal ultrasound or cross-sectional imaging or elevated inflammatory markers (CRP)
  • Initiating advanced therapy (anti-TNF agents, anti-integrin agents, anti-IL12/23, anti-IL23 agents, S1P receptor modulators, JAK inhibitors) for IBD per usual clinical care within 2 weeks of baseline/randomization, regardless of prior exposure to advanced therapies or disease duration
  • Other non-biologic IBD medications must remain stable during the treatment period and no medication changes are planned with the exception of tapering of corticosteroids.
  • Current disease activity defined as a Harvey Bradshaw index > 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index > 2 at baseline (week 0) for UC subjects or having had a recent exacerbation being treated with systemic steroids or budesonide.

Критерии исключения

  • Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study.
  • Initiation of advanced therapy for extra-intestinal symptoms alone
  • Known eating disorders
  • Already receiving dietary therapy or stress management interventions
  • Severe untreated psychiatric comorbidity including history of suicidal thoughts
  • Evidence of untreated infection (e.g. Clostridium difficile)
  • Presence of stoma or J-pouch
  • Female subjects who are pregnant, lactating, or intending to become pregnant during the study period
  • On total parental nutrition (TPN) or already following a therapeutic diet for IBD.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07168499 · 2025P001274

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗