About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients diagnosed with anorexia nervosa (all subtypes)
patients diagnosed bulimia nervosa
Disqualifiers
patients that are medically unable to fill out a short questionnaire on a weekly base.
Trial population
Patients with Anorexia nervosa and Bulimia nervosa. All subtypes will be included.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Gastrointestinal Symptoms
Score of the Gastrointestinal Symptom Rating Scale assessed upon admission and discharge (two time points), in relation to the predominant dietary pattern (\>80% during the rehabilitation phase), defined as flexitarian, vegetarian, or vegan and body weight development. The Gastrointestinal Symptom Rating Scale is a validated questionnaire : Svedlund J, Sjödin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. (1988) 33(2):129-34. doi: 10.1007/BF01535722. The primary outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.
Secondary outcomes
Gastrointestinal Symptoms in the Timecourse
The Gastrointestinal Symptom Rating Scale is assessed weekly during inpatient treament.
Dietary intake
Dietary intake is closely monitored from the beginning to the end of the inpatients stay. The data of the plans will be summarized weekly, containing information on the intake of macro- and micronutrients, fibre, energy intake and food groups. The outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.
Body weight
Body weight in kg is measured in underwear in the morning before breakfast using a calibrated scale in order to calculate the Body mass index or body mass index z-score. The outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.
Body height
Body height in cm is measured using a standardized stadiometer to calculate the body mass index or the body mass index z-score. The outcome is analyzed seperately for patients with anorexia nervosa and bulimia nervosa.
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