Gastrointestinal Microbiota & Symptoms of Depression and Anxiety in Anorexia Nervosa-A Re-Analysis of the MICROBIAN Longitudinal Study.
Jasmin Ketel, Miquel Bosch-Bruguera, Greta Auchter...
https://pubmed.ncbi.nlm.nih.gov/38542802Actively Recruiting
Age: 12Years +
All Genders
ID07112014
Development of Gastrointestinal Symptoms in Patients With Anorexia Nervosa and Bulimia Nervosa During Weight Rehabilitation Over Time, Depending on the Nutritional Strategy
Led by University Hospital Tuebingen · Updated on 2025-09-23
185
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how gastrointestinal (GI) symptoms develop in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during multi-week inpatient weight rehabilitation. The study focuses on how different dietary approaches—flexitarian, vegetarian, or vegan—relate to changes in GI symptoms throughout treatment. It also examines how weight gain, clinical factors, psychological status, and demographic details influence GI symptoms over time. The main goal is to understand symptom changes from admission to discharge using a GI symptom severity score, with analyses done separately for AN and BN groups. Participants are patients with AN or BN undergoing standard inpatient treatment aimed at weight rehabilitation and normalizing eating behavior at a specialized eating disorder center. During their stay, patients follow usual diagnostic and treatment procedures while detailed data on dietary intake and GI symptoms are collected. GI symptoms are assessed upon admission, weekly during hospitalization, and at discharge. The study tracks other clinical measurements such as body weight, body composition, and psychological assessments. Participants complete weekly questionnaires about GI symptoms as part of their routine care. Researchers collect body weight, composition, and various psychological survey data at admission and discharge, with some tests repeated weekly. Laboratory tests including blood counts and metabolic panels are also gathered regularly. The primary outcome measures the change in GI symptoms from admission to discharge, while secondary analyses evaluate symptoms over time, dietary impact, and clinical predictors. The study plans to enroll about 150 AN and 35-40 BN patients, with total participation spanning their inpatient stay.
CONDITIONS
Brief Title
Development of Gastrointestinal Symptoms in Patients With Anorexia Nervosa and Bulimia Nervosa During Weight Rehabilitation Over Time, Depending on the Nutritional Strategy
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with anorexia nervosa (all subtypes)
- Patients diagnosed with bulimia nervosa
- Age 12 years or older
- Clinically stable
- Able to provide informed consent
You will not qualify if you...
- Medically unable to complete a short weekly questionnaire
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Multi-week inpatient stay
Participants complete weekly questionnaires and undergo clinical assessments as part of their multi-week inpatient weight rehabilitation program. Data on gastrointestinal symptoms, dietary intake, body weight, body composition, and psychological status are collected regularly during the inpatient stay.
Weekly visits for assessments during the inpatient stay
Monitoring
Duration - Final 3 days before discharge
Participants' gastrointestinal symptoms, dietary intake, body measurements, and psychological assessments are collected within the final days before discharge to evaluate changes over the course of treatment.
1 visit (in-person) at discharge
Trial Site Locations
Total: 1 location
1
Klinik Lüneburger Heide
Bad Bevensen, Germany, 29549
Actively Recruiting
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Research Team
I
Isabelle Mack, Prof. Dr.
M
Marc Leiteritz, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Weight gain in anorexia nervosa does not ameliorate the faecal microbiota, branched chain fatty acid profiles, and gastrointestinal complaints.
Isabelle Mack, Ulrich Cuntz, Claudia Grämer...
https://pubmed.ncbi.nlm.nih.gov/27229737Which Symptoms, Complaints and Complications of the Gastrointestinal Tract Occur in Patients With Eating Disorders? A Systematic Review and Quantitative Analysis.
Caroline Riedlinger, Greta Schmidt, Alisa Weiland...
https://pubmed.ncbi.nlm.nih.gov/32425816Gastrointestinal complaints in patients with anorexia nervosa in the timecourse of inpatient treatment.
Caroline Riedlinger, Nazar Mazurak, Norbert Schäffeler...
https://pubmed.ncbi.nlm.nih.gov/36061281