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

Sponsor
University Hospital Tuebingen
Study ID
NCT07112014
Status
Recruiting
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Conditions

  • Anorexia Nervosa
  • Bulimia Nervosa

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 8, 2025
Start date
Sep 9, 2025
Status verified
Jul 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
185 participants (estimated)

Arms

  • Arm: Patients with anorexia nervosa and bulimia nervosa
    The study population includes patients with anorexia nervosa (AN) and bulimia nervosa (BN) who participate in an established, multi-week inpatient treatment program aimed at weight rehabilitation and normalization of eating behavior at the Eating Disorder Center of the Klinik Lüneburger Heide in 29549 Bad Bevensen, Germany. The diagnostic and treatment of the patients is as usual. These data, including detailed data on dietary intake, are used for the study. Additionally, information on gastrointestinal sympoms are assessed upon admission and discharge and weekly during the inpatient stay. The outcomes will be analyzed seperately for patients with anorexia nervosa and bulimia nervosa.

Primary Outcome Measure

Gastrointestinal Symptoms [ Time Frame: Data are collected within the first three days after admission and during the final three days before discharge (two time points). ]

Central Contacts

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