University Rouen Hospital
Rouen, 76031, France
Location status: Recruiting
NCT Number: NCT07196189
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Observational
Rouen, 76031, France
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with ED
Healthy Volunteers
Exclusion criteria
Patients with ED
Healthy volunteers
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.
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.
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.
Time frame: month 1
Food and water intake will be monitored daily by weighing
Time frame: month 1
The body composition of the animals will be determined by echo-MRI (determination of fat mass and lean mass).
Time frame: month 1
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.
Time frame: month 1
Food and water intake will be monitored daily by weighing
Time frame: month 1
The body composition of the animals will be determined by echo-MRI (determination of fat mass and lean mass).
Time frame: month 1
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.
Time frame: Month 1
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.
Contact information is provided by the study sponsor or research team.
Moïse MC COEFFIER, Professor
CONTACT
02 35 14 82 45 ext. +33
Pierre PD DECHELOTTE, Professor
CONTACT
02 32 88 64 65 ext. +33
University Hospital, Rouen
Other
Effects of Fecal Microbiota Transplantation From Patients With Eating Disorders on Body Weight Development in Mice
Acronym: Transmic-TCA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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