Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
14 participants
INTERVENTIONAL
2023-10-13
2024-02-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Microbiological Profile of Stool in Patients With Anorexia Nervosa
NCT03736642
Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa
NCT05632497
The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa
NCT07143981
Feasibility Study of Using Fecal Microbiota Transplants in Anorexia Nervosa
NCT05834010
Microbiome-mediated Weight, Anxiety, and Stress Dysregulation in Anorexia Nervosa
NCT03119272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acute anorexia nervosa
patient diagnose for a first episode of pure restrictive anorexia nervosa will be included. They will have stool sample and Food intake evaluation.
Stool sample
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
Food intake evaluation
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Chronic anorexia nervosa
Patient diagnose for anorexia nervosa at least 5 years ago and still maintaining a significant thinness will be included. They will have stool sample and Food intake evaluation.
Stool sample
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
Food intake evaluation
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Healthy control
Healthy Patient will be included. They will have stool sample and Food intake evaluation.
Stool sample
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
Food intake evaluation
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stool sample
Purification by affinity of the IgA coated bacteria from a fecal solution. Genomic analysis of the bacteria for diversity and richness
Food intake evaluation
Measure (by survey) of food group intake for : lipids /proteins / fibers / carbohydrates
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* presenting a diagnosis of pure restrictive anorexia nervosa.
For acute subgroup : BMI between 11 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes.
For the chronic subgroup: BMI between 11 and 17.5 kg/m2, disease evolving for more than 5 years.
For Healthy volunteer: BMI between 20 and 24 kg/m², stable weight for the last 3 months, no eating disorder or history of eating disorder
Exclusion Criteria
* laxative treatment in progress or stopped for less than 15 days,
* antibiotic treatment in the two months preceding inclusion,
* pre-pro or symbiotic treatment in progress or in the month preceding inclusion,
* patient with one of the following comorbid disorders: celiac disease, chronic inflammatory bowel disease, lactose intolerance, unstabilized hyperthyroidism, unstabilized diabetes,
* subject under legal protective measures.
18 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
OTHER
Laboratory Physiopathologie et biotherapies des infections muqueuses (GIMAP)
UNKNOWN
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tristan GABRIEL-SEGARD, Md
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Saint-Etienne
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-A00318-37
Identifier Type: OTHER
Identifier Source: secondary_id
22CH356
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.