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Идёт набор NCT07112014

Development of Gastrointestinal Symptoms in Patients With Anorexia Nervosa and Bulimia Nervosa During Weight Rehabilitation Over Time, Depending on the Nutritional Strategy

Наблюдательное Anorexia Nervosa Bulimia Nervosa

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Anorexia Nervosa, Bulimia Nervosa. Базовые параметры: от 12 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This prospective observational study investigates the development of gastrointestinal (GI) symptoms in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during multi-week inpatient weight rehabilitation. The study explores how the predominant nutritional strategy-flexitarian, vegetarian, or vegan-relates to changes in GI symptoms over the course of treatment. In addition to diet, the study examines how weight gain and other clinical, psychological, and demographic factors influence the trajectory of GI symptoms. Patients complete weekly questionnaires assessing GI symptoms as part of routine care at the Eating Disorder Center of the Klinik Lüneburger Heide, Germany. Further data are drawn from standard clinical assessments, including body weight, body composition, and psychometric instruments. The primary outcome is the change in GI symptom severity (measured via the GSRS score) from admission to discharge, analyzed in relation to dietary pattern and weight development. Secondary analyses will explore symptom progression over time, group differences between AN and BN, and predictors of GI symptom improvement, including dietary intake, baseline psychological status, symptom change, weight trajectory, and treatment duration. The outcomes will be analyzed separately for AN and BN. The study aims to recruit approximately 150 patients with AN and 35-40 with BN. Inclusion requires a diagnosis of AN (any subtype) or BN, age over 12 years, clinical stability, and the ability to provide informed consent. The findings aim to inform evidence-based dietary recommendations for individuals with eating disorders who experience significant GI symptoms during nutritional rehabilitation.

Подробное описание

This prospective observational study investigates the development of gastrointestinal (GI) symptoms in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during multi-week inpatient weight rehabilitation. The study explores how the predominant nutritional strategy-flexitarian, vegetarian, or vegan-relates to changes in GI symptoms over the course of treatment. In addition to diet, the study examines how weight gain and other clinical, psychological, and demographic factors influence the trajectory of GI symptoms. Patients complete weekly questionnaires assessing GI symptoms as part of routine care at the Eating Disorder Center of the Klinik Lüneburger Heide, Germany. Further data are drawn from standard clinical assessments, including body weight, body composition, and psychometric instruments. The primary outcome is the change in GI symptom severity (measured via the GSRS score) from admission to discharge, analyzed in relation to dietary pattern and weight development. Secondary analyses will explore symptom progression over time, group differences between AN and BN, and predictors of GI symptom improvement, including dietary intake, baseline psychological status, symptom change, weight trajectory, and treatment duration. The study aims to recruit approximately 150 patients with AN and 35-40 with BN. Inclusion requires a diagnosis of AN (any subtype) or BN, age over 12 years, clinical stability, and the ability to provide informed consent. The findings aim to inform evidence-based dietary recommendations for individuals with eating disorders who experience significant GI symptoms during nutritional rehabilitation.

Первичные конечные точки

  • Gastrointestinal Symptoms [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
Вторичные конечные точки (12)
  • Gastrointestinal Symptoms in the Timecourse [Срок оценки: Data are continuously collected from admission to discharge. Extraction occurs on the first three days of admission, weekly during the stay (on Mondays or Tuesdays, covering the preceding week), and on the final three days of discharge.]
  • Dietary intake [Срок оценки: Data are continuously collected throughout the inpatient stay. Extraction takes place on the day of admission, weekly during the stay (on Mondays or Tuesdays, reflecting the data of the preceding week), and on the day of discharge.]
  • Body weight [Срок оценки: Data are continuously collected from admission to discharge. Extraction occurs the second day in the morning after admission, weekly during the stay (on Mondays or Tuesdays), and at the day of discharge]
  • Body height [Срок оценки: Body weight is measured within the first two days after admission and again within the final two days prior to discharge. For inpatient stays exceeding three months, weight measurements are repeated at three-month intervals.]
  • Body composition [Срок оценки: Body composition is measured within the first two days after admission and again within the final two days prior to discharge. The outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.]
  • Eating Disorder Inventory-2 (EDI-2) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
  • Three Factor Eating Questionnaire (TFEQ) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
  • Symptom-Checkliste (SCL-90-R) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
  • Beck-Depressions-Inventar Revision (BDI-II) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
  • Obsessive Compulsive Inventory - Revised (OCI-R) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
  • Generalizied Anxiety Disorder Scale-7 (GAD-7) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]
  • Wender Utah Rating Scale (WURS-K) [Срок оценки: Data are collected within the first three days after admission and during the final three days before discharge (two time points).]

Критерии участия

Критерии включения

  • patients diagnosed with anorexia nervosa (all subtypes)
  • patients diagnosed bulimia nervosa

Критерии исключения

  • patients that are medically unable to fill out a short questionnaire on a weekly base.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Klinik Lüneburger Heide — Bad Bevensen

Публикации

  • Ketel J, Bosch-Bruguera M, Auchter G, Cuntz U, Zipfel S, Enck P, Mack I. Gastrointestinal Microbiota & Symptoms of Depression and Anxiety in Anorexia Nervosa-A Re-Analysis of the MICROBIAN Longitudinal Study. Nutrients. 2024 Mar 19;16(6):891. doi: 10.3390/nu16060891. PMID 38542802
  • Mack I, Cuntz U, Gramer C, Niedermaier S, Pohl C, Schwiertz A, Zimmermann K, Zipfel S, Enck P, Penders J. Weight gain in anorexia nervosa does not ameliorate the faecal microbiota, branched chain fatty acid profiles, and gastrointestinal complaints. Sci Rep. 2016 May 27;6:26752. doi: 10.1038/srep26752. PMID 27229737
  • Riedlinger C, Schmidt G, Weiland A, Stengel A, Giel KE, Zipfel S, Enck P, Mack I. Which Symptoms, Complaints and Complications of the Gastrointestinal Tract Occur in Patients With Eating Disorders? A Systematic Review and Quantitative Analysis. Front Psychiatry. 2020 Apr 20;11:195. doi: 10.3389/fpsyt.2020.00195. eCollection 2020. PMID 32425816
  • Riedlinger C, Mazurak N, Schaffeler N, Stengel A, Giel KE, Zipfel S, Enck P, Mack I. Gastrointestinal complaints in patients with anorexia nervosa in the timecourse of inpatient treatment. Front Psychiatry. 2022 Aug 18;13:962837. doi: 10.3389/fpsyt.2022.962837. eCollection 2022. PMID 36061281

Идентификаторы

NCT: NCT07112014 · GastroRehab

Первоисточники (государственные реестры)

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