Effects of Fecal Microbiota Transplantation

NCT07196189 | Recruiting

• 2 other identifiers: 2020/289/OB2020-A02543-36
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The intestinal microbiota plays an essential role in digestion and, through the gut-brain axis, in the regulation of weight gain and eating behavior. The balaEating disorders (EDs) are serious pathologies affecting adolescence and young adults, likely to become chronic, with long-term morbidity and mortality impacts. These pathologies represent a very important public health issue. EDs are defined by the DSM-V classification criteria and include different forms: anorexia nervosa, bulimia nervosa, hyperphagia, and atypical or unspecified forms. The global prevalence of these diseases reaches 8.4% in women and 2.2% in men. These eating disorders lead to numerous psychiatric and somatic complications and have a significant impact on the quality of life and mortality of patients (particularly in anorexic patients). The molecular mechanisms underlying eating disorders are still poorly understood. The etiological origin of these diseases is complex and involves various biological, psychological, and sociocultural factors. The intestinal microbiota, which corresponds to the community of microorganisms living inside the intestine, could be one of these factors. Indeed, the microorganisms of the microbiota interact very closely with intestinal cells but also with distant organs, such as the brain, via nerve communications or the bloodstream. nce and dialogue between the intestinal microbiota and human cells can be altered following changes in the environment, diet, or stress. These disturbances, found among others in patients suffering from eating disorders, can lead to a lasting change in the composition or metabolic activity of the microbiota (dysbiosis), which can have profound repercussions on human physiology. Several clinical studies conducted on patients with anorexia have highlighted the existence of intestinal dysbiosis in these individuals. As with anorexia, the potential role of intestinal dysbiosis in bulimic and binge eating patients remains currently unknown. This dysbiosis could have a harmful effect on intestinal physiology and promote the onset of functional digestive disorders, which are frequently found in patients suffering from eating disorders. This dysbiosis could also lead to a disruption of communication along the gut-brain axis and contribute to the eating disorders observed in these patients.

Conditions

Eating Disorders Symptoms

Keywords

intestinal dysbiosis; intestinal physiology

Outcome Measures

Primary Outcomes (1)

• Body weight assessment of mice receiving fecal microbiota from patients suffering from eating disorders

  After collecting stool samples from the patient with eating disorders (ED) or the healthy volunteer, a suspension will be created from the stool samples of the patients or healthy volunteers. This suspension will be transplanted by oral gavage into C57Bl/6 mice whose endogenous microbiota will have been previously eliminated by the administration of antibiotics. Over time, the body weight of the transplanted animals will be evaluated. The main objective of this study is to evaluate the evolution of body weight in mice that received a fecal microbiota transplant from patients with eating disorders and to compare it with that of mice that received a microbiota transplant from healthy volunteers.

  Day 1

Secondary Outcomes (7)

• Evaluating feeding behavior in response to microbiota transplantation from TCA patients in mice

  month 1

• Evaluating body composition in response to microbiota transplantation from TCA patients in mice

  month 1

• Evaluating the occurrence of functional digestive disorders in response to microbiota transplantation from TCA patients in mice

  month 1

• Evaluating feeding behavior in response to microbiota transplantation from healthy volunteer in mice

  month 1

• Evaluating body composition in response to microbiota transplantation from healthy volunteer in mice

  month 1

Interventions

Patients OTHER

A clinical examination (weight, height, Body Mass Index calculation) and ED screening using the SCOFF questionnaire will then be carried out, allowing the patients eligibility criteria to be verified. If the patient is included, the self-questionnaire will be completed on site and stool collection will be carried out.

healthy volunteer OTHER

A clinical examination (weight, height, Body Mass Index calculation) and ED screening using the SCOFF questionnaire will then be carried out, allowing the volunteer's eligibility criteria to be verified. If the volunteer is included, the self-questionnaire will be completed on site and stool collection will be carried out.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with eating disorders (ED) first-time consultants in order to limit potential interference from previous medical treatments or nutritional support and healthy volunteers not presenting with eating disorders.

You may qualify if:

• Patients with ED
• Women.
• Aged 18 to 50.
• First consultation in the Nutrition Department of Rouen University Hospital for ED.
• Positive SCOFF with diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder.
• Affiliation with a social security plan.
• Patient who has read and understood the information letter and does not object to participating in the study.
• Healthy Volunteers
• Women.
• Aged 18 to 50.
• Body mass index between 18.5 and 24.9 kg/m².
• SCOFF test: no positive response.
• No history of ED or active ED (DSM V criteria negative).
• Affiliation with a social security plan.
• Individual who has read and understood the information letter and does not object to participating in the study.

You may not qualify if:

• Patients with ED
• Men.
• Aged under 18 and over 50.
• Negative SCOFF.
• Patients who have received antibiotic treatment in the last 3 months.
• Patients with a history of IBD or surgical procedures on the digestive tract.
• Patient refuses to participate in the study.
• Persons deprived of liberty by judicial or administrative order.
• Pregnant or breastfeeding women.
• Protected persons (guardianship or curatorship).
• Healthy volunteers
• Men.
• Aged under 18 and over 50.
• SCOFF test with at least one positive response.
• History or active ED (DSM V criteria).

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool samples used from independent individuals (healthy volunteers or patients)

Central Study Contacts

Pierre PD DECHELOTTE, Professor

CONTACT

02 32 88 64 65; Pierre.Dechelotte@chu-rouen.fr

Moïse MC COEFFIER, Professor

CONTACT

02 35 14 82 45; moise.coeffier@univ-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 29, 2025
• Study Start: March 16, 2022
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): April 16, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)