Investigating the link between food intake and gut bacteria in anorexia nervosa
Food Intake and IgA Microbiota in Anorexia Nervosa
NA · Centre Hospitalier Universitaire de Saint Etienne · NCT05842343
This study is trying to see how the food people with anorexia nervosa eat affects their gut bacteria and immune system compared to healthy individuals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne (other) |
| Locations | 1 site (Saint-Étienne) |
| Trial ID | NCT05842343 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between food intake and the IgA-coated bacteria in the intestinal microbiota of patients with anorexia nervosa. By analyzing stool samples and evaluating food intake, the research seeks to understand how these factors influence the mucosal immune system and the physiology of the gut. The study will focus on both acute and chronic cases of anorexia nervosa, as well as healthy volunteers, to identify potential differences in microbiota composition and its implications for treatment.
Who should consider this trial
Good fit: Ideal candidates include adult females diagnosed with restrictive anorexia nervosa, either in an acute or chronic phase, as well as healthy volunteers with stable weight.
Not a fit: Patients who do not understand French or have ongoing treatments that could interfere with the study, such as laxatives or antibiotics, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for anorexia nervosa by targeting the gut-brain axis.
How similar studies have performed: While the relationship between microbiota and mental health is an emerging field, this specific approach focusing on IgA microbiota in anorexia nervosa is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * female subject, adult, affiliated to a social security system, under the care of the eating disorder department of university hospital of st Etienne * 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: * patient does not understand French. * 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.
Where this trial is running
Saint-Étienne
- Chu Saint-Etienne — Saint-Étienne, France (RECRUITING)
Study contacts
- Principal investigator: Tristan GABRIEL-SEGARD, Md — CHU SAINT-ETIENNE
- Study coordinator: Tristan GABRIEL-SEGARD, Md
- Email: Tristan.Gabriel-Segard@chu-st-etienne.fr
- Phone: 04 77 12 02 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anorexia Nervosa, Healthy Volunteer, anorexia nervosa, microbiota, gut-brain-axis, immunology