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 2stools per day

• Subject with health insurance (AME excepted)

• Informed written consent

Exclusion Criteria:

Definitive non-inclusion criteria:

1. Infectious risk :

• Known HIV, HBV, HCV, HTLV infection

• Residence of more than 2 years in the intertropics zone within the previous 5years

• Hospitalization abroad for more than 24 hours in the last 12 months (includinga member of the healthy volunteers donor's entourage)

• Risk factors for Creutzfeldt-Jakob disease (history: treatment with extractivegrowth hormone, a family case of transmissible spongiform subacuteencephalopathy, surgery with opening of the dura or neurosurgery or invasivebrain exploration before 1 January 1995, stay in United Kingdom for a durationgreater than 1 year cumulatively between 1980 and 1996 or the presence ofneurological 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 celiacdisease

• Personal history of irritable bowel syndrome, idiopathic chronic constipationor 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

• If family history unknown in the first degree, the donor is not eligible

4. Previous history of :

• Subject prone to hemorrhoids (at least 1 event within the previous 1 year)

• Subject with an active chronic illness (except active chronic mild allergicdisease o (example: allergic rhinitis, chronic eczema...))

• Diagnosis of Gilbert's syndrome done by screening is not a chronicdisease. The healthy volunteer donor will therefore remain eligible.

• Serious allergy requiring hospitalization within the previous 12 months

• Curative long-term treatment

• Severe allergy requiring hospitalization in the last 12 months

• Allogeneic human or animal tissue or organ transplant

• 5- Factors that may affect the composition of the intestinal microbiota:

• Special Diet (example: gluten-free...)

• Lactose-free, vegetarian and vegan diets are permitted.

• Pregnancy or breastfeeding

• Taking immunosuppressants (eg calcineurin inhibitors, corticosteroids,biological agents, etc.)

• Antineoplastic chemotherapy

6- Subject under legal protection 7- Participation in any other interventional study except studies for stool donation Temporary non-inclusion criteria

1. Infectious risk :

• Unprotected sexual intercourse with a new partner in the previous 4 monthsand/or sexual intercourse with several different persons within the previous 4months

• sexual partner who has had more than 1 partner within the previous 4 monthsand/or

• sexual transmitted infection within the previous 4 months (healthy volunteerdonor 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, viralhepatitis B or C, in the last 6 months.

• Sexual relationship with a partner who has used intravenous drugs, dopingsubstances

• Hospitalization abroad for more than 24 hours in the last 12 months (healthyvolunteer 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.ewho have been hospitalized) within the previous 4 months

• Blood exposure accident (for wound, pricking or projection ...) within theprevious 4 months

• Dental care within the previous 7 days

• Gastroenteritis within the previous 3 months (defined by acute onset ofdiarrhea (> 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 PubliqueFrance with a person whose infection is confirmed or suspected: "14 days afterthe last risky contact: if the recommended screening tests in the event ofrisky contact between D15-D28 are negative "In the 28 days preceding inclusionin the absence of a screening test. Healthcare professionals using recommendedprotective measures with COVID patients are not considered high-risk contacts 3- Monkeypox risk

• Confirmed or suspected infection within the previous 42 days ( after beginningof symptoms)

• Risky contact with a person with confirmed or suspected infection within theprevious 21 days (from the date of last contact)

• Person who received the vaccine Imvanex within the previous 28 days ( after thelast 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 monthbefore donation

• Taking corticosteroids (oral) in the previous 4 weeks before donation.Corticosteroids allowed if taken more than 4 weeks before donation. and not foran autoimmune or inflammatory disease.

Temporary or permanent exclusion criteria:

• At each visit of the donation period, the temporary or definitive exclusion criteria (identical to the temporary or definitive non-inclusion criteria) will be rechecked