Eating Disorders SymptomsTransmic-TCANCT07196189
Effects of Fecal Microbiota Transplantation
An observational study of Eating Disorders Symptoms, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders Symptoms
- What is being tested?
- Patients and healthy volunteer
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2022to 16 Apr 2027
- How long will I take part?
- 1 Day
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
- Persons who have received antibiotic treatment in the last 3 months.
- Person with a history of IBD or surgical procedures on the digestive tract.
- Body mass index less than 18.5 or greater than 24.9 kg/m2.
- Pregnant or breastfeeding women.
- Protected persons (guardianship or curatorship).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Rouen Hospital
Rouen, 76031
Pierre PD DECHELOTTE, Professor, 02 32 88 64 65 ext. +33, Pierre.Dechelotte@chu-rouen.fr
About this study
Official title: Effects of Fecal Microbiota Transplantation From Patients With Eating Disorders on Body Weight Development in Mice
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.
Read the detailed description
The hypothesis of this study is that patients suffering from eating disorders exhibit intestinal dysbiosis that impacts intestinal physiology and eating behavior. This project aims to demonstrate the causal link between this dysbiosis and alterations in intestinal physiology and/or behavior by performing intestinal microbiota transplants in mice from patients spanning the entire spectrum of eating disorders (anorexic, bulimic, binge-eating). The onset of functional digestive disorders and eating disorders in these animals will then be assessed. These results will be compared to those obtained after microbiota transplants from healthy individuals.
These fecal microbiota transplant experiments will allow us to demonstrate the potential involvement of the intestinal microbiota in the onset or maintenance of eating disorders and functional digestive disorders associated with eating disorders. The treatment of functional digestive disorders would constitute an interesting strategy to improve the quality of life of patients suffering from ED and increase the effectiveness of current treatments against this class of pathologies. The demonstration of a role of the intestinal microbiota in the onset or maintenance of EDs would open the way to new therapeutic approaches aimed at modulating the intestinal microbiota of patients in order to restore the microorganism/host balance, reduce alterations in intestinal physiology, and restore communication along the gut-brain axis.
- Conditions
- Eating Disorders Symptoms
- Being tested
- Patients, healthy volunteer
- Keywords
- intestinal dysbiosis, intestinal physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsOther
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 volunteerOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (7)
Evaluating feeding behavior in response to microbiota transplantation from TCA patients in mice
Food and water intake will be monitored daily by weighing
Measured: month 1
Evaluating body composition in response to microbiota transplantation from TCA patients in mice
The body composition of the animals will be determined by echo-MRI (determination of fat mass and lean mass).
Measured: month 1
Evaluating the occurrence of functional digestive disorders in response to microbiota transplantation from TCA patients in mice
The occurrence of functional digestive disorders will be assessed by quantifying the efficiency of gastric emptying, the speed of intestinal transit and the water content of feces in grafted mice.
Measured: month 1
Evaluating feeding behavior in response to microbiota transplantation from healthy volunteer in mice
Food and water intake will be monitored daily by weighing
Measured: month 1
Evaluating body composition in response to microbiota transplantation from healthy volunteer in mice
The body composition of the animals will be determined by echo-MRI (determination of fat mass and lean mass).
Measured: month 1
Evaluating the occurrence of functional digestive disorders in response to microbiota transplantation from healthy volunteer in mice
The occurrence of functional digestive disorders will be assessed by quantifying the efficiency of gastric emptying, the speed of intestinal transit and the water content of feces in grafted mice.
Measured: month 1
To assess the occurrence of anxious/depressive behaviors in response to microbiota transplantation from TCA patients or healthy volunteers
Each parameter measured in mice after microbiota transplantation (body weight, food intake, intestinal transit time, intestinal permeability, behavioral parameters, etc.) will be compared between the different groups of mice (mice receiving a fecal microbiota transplant from a patient suffering from TCA compared to mice receiving a fecal microbiota transplant from healthy volunteers) using one-way or two-way ANOVA tests, with correction for multiple comparisons.
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start16 Mar 2022
- Primary completion16 Nov 2026 (estimated)
- Study completion16 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating Disorders SymptomsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07196189
- Sponsor's protocol ID
- 2020/289/OB
- Other IDs
- 2020-A02543-36
- Acronym
- Transmic-TCA
- Status last verified
- Apr 2025
- First submitted
- 15 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fecal Microbiota Transplantation From Patients With Eating Disorders on Body Weight Development in Mice
- ClinicalTrials.gov ID
- NCT07196189
- Acronym / sponsor ID
- Transmic-TCA / 2020/289/OB
- Conditions
- Eating Disorders Symptoms
- Keywords
- intestinal dysbiosis, intestinal physiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 16 Nov 2026 (estimated)
- Study completion
- 16 Apr 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis of this study is that patients suffering from eating disorders exhibit intestinal dysbiosis that impacts intestinal physiology and eating behavior. This project aims to demonstrate the causal link between this dysbiosis and alterations in intestinal physiology and/or behavior by performing intestinal microbiota transplants in mice from patients spanning the entire spectrum of eating disorders (anorexic, bulimic, binge-eating). The onset of functional digestive disorders and eating disorders in these animals will then be assessed. These results will be compared to those obtained after microbiota transplants from healthy individuals.
These fecal microbiota transplant experiments will allow us to demonstrate the potential involvement of the intestinal microbiota in the onset or maintenance of eating disorders and functional digestive disorders associated with eating disorders. The treatment of functional digestive disorders would constitute an interesting strategy to improve the quality of life of patients suffering from ED and increase the effectiveness of current treatments against this class of pathologies. The demonstration of a role of the intestinal microbiota in the onset or maintenance of EDs would open the way to new therapeutic approaches aimed at modulating the intestinal microbiota of patients in order to restore the microorganism/host balance, reduce alterations in intestinal physiology, and restore communication along the gut-brain axis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (20 listed)
- Patients with ED
- Men.
- Aged under 18 and over 50.
- Negative SCOFF.
- Patients who have received antibiotic treatment in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientsA 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. | Other | – |
| healthy volunteerA 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. | Other | – |
Primary outcome
Body weight assessment of mice receiving fecal microbiota from patients suffering from eating disorders
Time frame: Day 1
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.
7 secondary outcomes
Evaluating feeding behavior in response to microbiota transplantation from TCA patients in mice
Time frame: month 1
Evaluating body composition in response to microbiota transplantation from TCA patients in mice
Time frame: month 1
Evaluating the occurrence of functional digestive disorders in response to microbiota transplantation from TCA patients in mice
Time frame: month 1
Evaluating feeding behavior in response to microbiota transplantation from healthy volunteer in mice
Time frame: month 1
Evaluating body composition in response to microbiota transplantation from healthy volunteer in mice
Time frame: month 1
Evaluating the occurrence of functional digestive disorders in response to microbiota transplantation from healthy volunteer in mice
Time frame: month 1
To assess the occurrence of anxious/depressive behaviors in response to microbiota transplantation from TCA patients or healthy volunteers
Time frame: Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders Symptoms, run by University Hospital, Rouen at 1 site in France.
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 15 inclusion and 20 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 29 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 France. 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 Pierre PD DECHELOTTE, Professor (02 32 88 64 65 ext. +33, Pierre.Dechelotte@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight assessment of mice receiving fecal microbiota from patients suffering from eating disorders (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.