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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorUniversity Hospital Tuebingen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

185 Participants
are grouped into 1 trial group
Group A: Patients with anorexia nervosa and bulimia nervosa

Trial outcomes

Primary outcomes

1

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.

Time frame
Data are collected within the first three days after admission and during the final three days before discharge (two time points).

Secondary outcomes

1

Gastrointestinal Symptoms in the Timecourse

The Gastrointestinal Symptom Rating Scale is assessed weekly during inpatient treament.

Time frame
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.
2

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.

Time frame
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.
3

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.

Time frame
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
4

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.

Time frame
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.

Other outcomes

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