Profiling Fecal Samples for Selection of Donors of Feces

Study Overview
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Brief Summary
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Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis …. A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure.

Detailed Description
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Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis …. A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure. The aim of our study is to measure fecal biochemical, microbial and immunological parameters that are known to influence gut homeostasis in a group of 40 healthy donors to establish a referential profile of human stools to optimize donor profiling, beyond the infectious parameters, to increase the success rate of FMT.

Official Title
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Profiling Fecal Samples to Optimize Selection of Stool Donors for Fecal Microbiota Transplantation

Conditions
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Fecal Microbiota Transplantation

Intervention / Treatment
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* Other: Questionnaire and fecal sample collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Healthy volunteers Participant having been informed of the study and having sign a consent to participation Patient affiliated with a social security or beneficiary of such a social protection Exclusion Criteria: Person subject to legal protection (guardianship, trusteeship, etc.) Chronic disease that can alter the intestinal microbiota: cancer or malignant disease, bowel disease, diabetes, hypertension, hypercholesterolemia, .... Presence in the 1st degree family of one of the chronic diseases mentioned above Blood in stools Chronic drug treatment likely to alter the intestinal microbiota Travel to a tropical country in the last 3 months or extended stay (> 3 months) for less than 1 year Hospitalization abroad (> 24h) in the last 12 months Hospitalization abroad (> 24h) of a family member living under the same roof during the last 12 months Medical consultation in the last 3 months (other than administrative) Contact with a person with an infectious or contagious disease for more than 3 months Digestive disorders / febrile gastroenteritis (diarrhea with fever) in the last 3 months Febrile illnesses for more than 3 months Antibiotic treatment in the last 3 months Treatment with PPIs in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy controls<br>Questionnaire and fecal sample collection | Other: Questionnaire and fecal sample collection<br>* Questionnaire and fecal sample collection in order to select donors for FMT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of fecal samples with search for differentiated fecal profiles. | 16S genomic analysis of microbiota will be performed for the evaluation of alpha and beta diversities of microbiota. Results will be aggregated to define differentiated faecal profiles in healthy volunteers. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of fecal biomarkers with search for differentiated fecal profiles. | Fecal biomarkers such as calprotectin will be dosed. Results will be aggregated to define differentiated faecal profiles in healthy volunteers. | At 12 months | 
| Quantification of colonic inflammation in mouse model. | The quantification of colonic inflammation by myeloperoxidase assay using a sandwich ELISA enzyme-linked immunosorbent assay. Mouse model : authorization APAFlS#7600-20l60620l6336853 v3 | At 15 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selection of healthy donors, Healthy volunteers, Stool donors, Fecal microbiota transplantation