Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials

Inclusion Criteria

• •\- Age ≥ 18 years and \< 50 years
• •17 kg/m² \< body mass index \< 30 kg/m²
• •Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
• •Subject with health insurance (AME excepted)
• •Informed written consent
• •1. Infectious risk :
• •\- Known HIV, HBV, HCV, HTLV infection
• •\- Residence of more than 2 years in the intertropics zone within the previous 5 years
• •\- Hospitalization abroad for more than 24 hours in the last 12 months (including a member of the healthy volunteers donor's entourage)
• •\- Risk factors for Creutzfeldt-Jakob disease (history: treatment with extractive growth hormone, a family case of transmissible spongiform subacute encephalopathy, surgery with opening of the dura or neurosurgery or invasive brain exploration before 1 January 1995, stay in United Kingdom for a duration greater than 1 year cumulatively between 1980 and 1996 or the presence of neurological or neuropsychiatric scalable recent clinical signs)
• •* Previous history of typhoid fever, tuberculosis and malaria
• •* Past or current injection drug user or regular use of other drug
• •2. Gastrointestinal disease:
• •\- Personal or 1st degree family history of: inflammatory bowel disease or celiac disease
• •\- Personal history of irritable bowel syndrome, idiopathic chronic constipation or chronic diarrhea
• •\- Previous history of gastrointestinal neoplasia or polyps
• •\- Family history of 1st degree gastrointestinal neoplasia or polyps before age 60
• •3. 1st degree family history of one of the following autoimmune or inflammatory disease : inflammatory arthritis, psoriasis, multiple sclerosis, type I diabetes, spondylitis, lupus and Basedow disease
• •1. Infectious risk :
• •* Unprotected sexual intercourse with a new partner in the previous 4 months and/or sexual intercourse with several different persons within the previous 4 months
• •* sexual partner who has had more than 1 partner within the previous 4 months and/or
• •* sexual transmitted infection within the previous 4 months (healthy volunteer donor himself or sexual partner)
• •* Sexual relationship in exchange for money or drugs in the last 12 months. (healthy volunteer donor himself or sexual partner)
• •* Sexual relationship with a partner with positive serology for HIV, viral hepatitis B or C, in the last 6 months.
• •* Sexual relationship with a partner who has used intravenous drugs, doping substances
• •* Hospitalization abroad for more than 24 hours in the last 12 months (healthy volunteer or entourage)
• •* Travelling within the previous 3 months except : Germany, Austria, Belgium, Spain, Finland, Ireland, Italia, Luxembourg, Netherland, Portugal, Greece, Slovenia, Cyprus, Malta, Slovakia, Estonia , Bulgaria, Croatia , Hungary, Latvia , Lithuania, Poland , Romania, Czech Republic, the United Kingdom, Denmark, Norway, Sweden, Switzerland, USA or Canada.
• •* Blood transfusion, piercing (including earrings) or tattoo within the previous 4 months
• •* Surgery (all types) or hospitalization within the previous 4 months
• •* Person living under the same roof with an infectious or contagious disease (i.e who have been hospitalized) within the previous 4 months
• •* Blood exposure accident (for wound, pricking or projection ...) within the previous 4 months
• •* Dental care within the previous 7 days
• •* Gastroenteritis within the previous 3 months (defined by acute onset of diarrhea (\> 3 soft or liquid stools per day) and duration \< one week)
• •* Episode of infection or skin infection/lesion within the previous 15 days 2-Risk linked to Covid-19
• •* Confirmed infection in the previous 28 days (after symptoms have ceased)
• •* Clinical signs of suspected infection (chill, cough, fever, dyspnea, myalgia, asthenia, malaise, pharyngeal pain, anosmia , ageusia, rhinorrhea, chest pain, headache, diarrhea) in the previous 28 days (after the end of symptoms)
• •* Having been in risky contact (according to the definition of Santé Publique France with a person whose infection is confirmed or suspected: "14 days after the last risky contact: if the recommended screening tests in the event of risky contact between D15-D28 are negative "In the 28 days preceding inclusion in the absence of a screening test. Healthcare professionals using recommended protective measures with COVID patients are not considered high-risk contacts 3- Monkeypox risk
• •* Confirmed or suspected infection within the previous 42 days ( after beginning of symptoms)
• •* Risky contact with a person with confirmed or suspected infection within the previous 21 days (from the date of last contact)
• •* Person who received the vaccine Imvanex within the previous 28 days ( after the last injection).
• •4- vaccination in the previous 15 days
• •5- Factors that may affect the composition of the intestinal microbiota:
• •* Taking antibiotic or antifungal (oral) in the previous 3 months before donation
• •* Taking non-steroidal anti-inflammatory drugs (oral) in the previous month before donation
• •* Taking corticosteroids (oral) in the previous 4 weeks before donation. Corticosteroids allowed if taken more than 4 weeks before donation. and not for an autoimmune or inflammatory disease.