Healthy stool donations for fecal microbiota transplantation

Healthy Stool Volunteer Donors for Fecal Microbiota Transplantation Trials

This study is trying to find the best ways to collect and check healthy stool donations for fecal microbiota transplants to make the process smoother and more effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 49 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Paris)
• Trial ID: NCT06478823 on ClinicalTrials.gov

What this trial studies

This study focuses on optimizing the process of collecting and validating stool donations from Healthy Volunteer Donors (HVD) for fecal microbiota transplantation (FMT) trials. It aims to identify the characteristics and lifestyle habits of HVD that correlate with the validity of their stool donations. By following a common protocol approved by ANSM, the study seeks to streamline the selection and inclusion of donors, thereby enhancing the efficiency of FMT trials. The research addresses complexities introduced by new COVID-19 recommendations and aims to improve the overall effectiveness of stool donation processes.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy individuals aged 18 to 50 with a body mass index between 17 and 30 and regular bowel movements.

Not a fit: Patients with infectious risks or specific health conditions that disqualify them from being stool donors will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the efficiency and reliability of fecal microbiota transplantation, potentially improving treatment outcomes for patients with gastrointestinal disorders.

How similar studies have performed: While the approach of optimizing stool donation processes is not widely tested, similar studies have shown promise in improving the efficiency of donor selection and stool collection.

Eligibility criteria

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

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 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

   \- 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 allergic disease o (example: allergic rhinitis, chronic eczema…))

     * Diagnosis of Gilbert's syndrome done by screening is not a chronic disease. 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 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.

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

Where this trial is running

Paris

• LRIPH CRC-Est SAT — Paris, France (Recruiting)

Study contacts

• Principal investigator: Mélissa Montil — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Mélissa Montil, Praticien attaché

Conditions Gastro-Intestinal Disorder; Healthy Volunteer stool Donors; Stools donations; Fecal microbiota transplantation