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Anorexia NervosaGastroRehabNCT07112014

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

An observational study of Anorexia Nervosa and Bulimia Nervosa, run by University Hospital Tuebingen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Anorexia Nervosa, Bulimia Nervosa
How many people
185 participants
Where
1 siteGermany
Study dates
9 Sep 2025to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with Anorexia nervosa and Bulimia nervosa. All subtypes will be included.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Isabelle Mack, Prof. Dr. contact

+49 070712985614

i.mack@uni-tuebingen.de

Marc Leiteritz, Dr. contact

m.leiteritz@klinik-lueneburger-heide.de

Germany1 site, 1 recruiting
  • Klinik Lüneburger Heide

    Bad Bevensen, 29549

    Marc Leiteritz, Dr., +49 58219600, m.leiteritz@klinik-lueneburger-heide.de

    Recruiting

Other trials in Germany

About this study

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.

Read the detailed description

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.

Keywords
gastrointestinal symptoms, gastrointestinal health, dietary regime, psychological health, vegetarian diet, vegan diet, balanced diet, energy intake
Medical subject headings
Anorexia Nervosa, Bulimia Nervosa, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07112014
Study groupRoleWhat they receive
Patients with anorexia nervosa and bulimia nervosaThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (21)
  1. Gastrointestinal Symptoms in the Timecourse

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

  5. Body composition

    Body composition is measured with bioelectrical impedance

    Measured: 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.

  6. Eating Disorder Inventory-2 (EDI-2)

    Eating Disorder Inventory-2 (EDI-2): A 91-item self-report questionnaire assessing psychological and behavioral traits related to eating disorders across 11 subscales. Each item is scored from 0 to 2; total scores range from 0 to 182, with higher scores indicating worse outcomes (greater symptom severity. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  7. Three Factor Eating Questionnaire (TFEQ)

    This is a self-report measure of eating behavior with 51 items across three subscales: Cognitive Restraint, Disinhibition, and Hunger. Items are primarily dichotomous (yes/no), with some Likert-scale items. Subscale scores vary in range, and the total score ranges from 0 to 51, with higher scores indicating worse outcomes (e.g., more disinhibited eating, greater hunger, or excessive restraint). Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  8. Symptom-Checkliste (SCL-90-R)

    Symptom-Checklist-90-Revised (SCL-90-R): A 90-item self-report questionnaire assessing general psychological distress across 9 symptom dimensions (e.g., depression, anxiety, somatization) and 3 global indices. Each item is rated from 0 (not at all) to 4 (extremely). Total scores range from 0 to 360, with higher scores indicating worse psychological symptom severity. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  9. Beck-Depressions-Inventar Revision (BDI-II)

    This is a 21-item self-report questionnaire assessing the severity of depressive symptoms over the past two weeks. Each item is rated on a scale from 0 to 3. Total scores range from 0 to 63, with higher scores indicating worse depressive symptom severity. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  10. Obsessive Compulsive Inventory - Revised (OCI-R)

    This is an 18-item self-report questionnaire measuring the severity of obsessive-compulsive symptoms across 6 subscales (e.g., washing, checking, hoarding). Each item is rated from 0 (not at all) to 4 (extremely). Total scores range from 0 to 72, with higher scores indicating worse obsessive-compulsive symptom severity. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  11. Generalizied Anxiety Disorder Scale-7 (GAD-7)

    This is a 7-item self-report questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is rated from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 21, with higher scores indicating worse anxiety symptom severity. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  12. Wender Utah Rating Scale (WURS-K)

    This is a 25-item self-report questionnaire assessing retrospective childhood symptoms of ADHD in adults. Each item is rated from 0 (not at all or never) to 4 (very much or very often). Total scores range from 0 to 100, with higher scores indicating greater severity of ADHD-related childhood symptoms. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  13. Subthreshold Autism Trait Questionnaire (SATQ)

    This is a 24-item self-report questionnaire measuring the presence of subclinical autistic traits in adults. Each item is rated from 0 (strongly disagree) to 3 (strongly agree). Total scores range from 0 to 72, with higher scores indicating more pronounced subthreshold autistic traits.Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  14. Frost Multidi-mensional Perfectionism Scale (FMPS)

    This is a 35-item self-report questionnaire assessing perfectionism across multiple dimensions, including concern over mistakes, personal standards, and parental expectations. Each item is rated from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 35 to 175, with higher scores indicating greater levels of perfectionism. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  15. Perceived Stress Questionnaire (PSQ)

    This is a self-report instrument assessing subjective experiences of stress over the past weeks. The standard version includes 30 items, each rated on a scale from 1 (almost never) to 4 (usually). Total scores range from 30 to 120, with higher scores indicating greater perceived stress. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

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

  16. Age

    Age is assessed by documenting the birth date (day, months, year) from the health insurance card.

    Measured: This is assessed upon admission.

  17. Complete Blood Count (CBC) with Differential

    Complete Blood Count (CBC) with Differential: A standard laboratory test used to assess general health and detect hematological abnormalities. Measures include red blood cells, white blood cells, hemoglobin, hematocrit, platelets, and a differential count of white blood cell subtypes (neutrophils, lymphocytes, monocytes, eosinophils, basophils). Results outside reference ranges may indicate infection, anemia, inflammation, or immune response abnormalities. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

    Measured: Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.

  18. Key electrolyte panel for fluid balance, neuromuscular function, and metabolic regulation

    A standard blood chemistry panel measuring key electrolytes involved in fluid balance, neuromuscular function, and metabolic regulation.

    Sodium (Na⁺): typically 135-145 mmol/L

    Potassium (K⁺): typically 3.5-5.0 mmol/L

    Chloride (Cl-): typically 98-107 mmol/L

    Magnesium (Mg²⁺): typically 0.7-1.0 mmol/L

    Phosphate (PO₄³-): typically 0.8-1.5 mmol/L Abnormal values may indicate renal dysfunction, metabolic imbalance, or effects of medications. Higher or lower levels indicate worse physiological regulation depending on the parameter. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

    Measured: Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.

  19. Liver Function Panel

    This Liver Function Panel (ALT, AST, GGT, ALP, Bilirubin, Albumin, INR) is a comprehensive blood test panel assessing hepatocellular injury and liver synthetic function.

    Alanine aminotransferase (ALT): < 50 U/L

    Aspartate aminotransferase (AST): < 50 U/L

    Gamma-glutamyl transferase (GGT): < 60 U/L

    Alkaline phosphatase (ALP): 35-125 U/L

    Total Bilirubin: 0.3-1.2 mg/dL

    Albumin: 3.5-5.0 g/dL

    International Normalized Ratio (INR): 0.9-1.2 Elevated enzyme levels may indicate hepatocellular injury or cholestasis, while changes in bilirubin, albumin, or INR reflect impaired liver function. Deviations from normal values indicate worsening liver status, depending on the parameter. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

    Measured: Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.

  20. Renal Function Panel

    This Renal Function Panel (Creatinine, Urea/BUN, eGFR) is a standard blood test panel assessing kidney function and glomerular filtration.

    Serum Creatinine: typically 0.6-1.3 mg/dL

    Blood Urea Nitrogen (BUN)/Urea: typically 7-20 mg/dL (or 2.5-7.1 mmol/L)

    Estimated Glomerular Filtration Rate (eGFR): > 90 mL/min/1.73 m² (normal) Abnormal values may indicate impaired renal function, dehydration, or nephrotoxic effects. Higher creatinine or BUN and lower eGFR indicate worse kidney function. Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

    Measured: Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.

  21. Medication Use

    Self-reported and/or medically verified use of prescribed or over-the-counter medications during the study period, with a focus on agents affecting gastrointestinal physiology. Values are recorded categorically (e.g., no medication, antidepressants, antipsychotics, anxiolytics, GI-active drugs, other). Data are analyzed separately for patients with anorexia nervosa and bulimia nervosa.

    Measured: Data will be analyzed from samples collected within the first 3 days after hospital admission, weekly throughout the inpatient stay (on or around Day 7, Day 14, etc.), and within the final 3 days prior to discharge.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study start9 Sep 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
185 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07112014
Sponsor's protocol ID
GastroRehab
Acronym
GastroRehab
Status last verified
Jul 2025
First submitted
15 Jul 2025
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient data. Potential collaborators should contact us directly.

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 36061281

Questions about this trial

What is this clinical trial studying?

An observational study of Anorexia Nervosa and Bulimia Nervosa, run by University Hospital Tuebingen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Isabelle Mack, Prof. Dr. (+49 070712985614, i.mack@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07112014, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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