TML.science assesses individual donor eligibility through a two-step verification process. The first step involves the completion of an Initial Donor Questionnaire, which serves as a rigorous screening tool to evaluate a potential donor’s suitability. This initial assessment is critical, as it helps to identify any health, lifestyle, or medical factors that may pose a risk to product safety or recipient health.
Due to its importance in safeguarding the quality and integrity of the FMT material, the Initial Donor Questionnaire is intentionally comprehensive and stringent. Only those individuals who meet the strict eligibility criteria outlined in this first stage are invited to proceed to the next phase of screening. This approach ensures that only the most suitable candidates advance in the donor qualification process, in line with our commitment to patient safety and regulatory compliance.Below questions asked but not limited to :
01-INITIAL SCREENING
- Their work environment
- Lifestyle (exercise, diet, smoking, drug use, alcohol use etc.).
- Dental health, including any dental surgery or fillings.
- Any metabolic syndrome (such as being overweight, having high blood pressure, fatty liver and/or diabetes).
- Health risk factors for HIV, syphilis, Hepatitis B, Hepatitis C, prion infection, or any neurological disease.
- Any blood transfusions in the past 6 months.
- Receipt of any systemic immunosuppressive agents at any time.
- Whether they are currently or have previously undergone chemotherapy treatment.
- New or multiple (more than one) sexual partners within the past 12 months.
- Travel History within the past 24 months
- BMI
- Bowel movement frequency and type (referenced against the Bristol Stool Chart), and any issues or use of medications related to their stool.
- Any tattoos, piercings, acupuncture or needlestick injuries within the past 6 months.
- Any type of active or past cancer or autoimmune disease.
- Any gastrointestinal comorbidities, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation, or diarrhoea.
- Any use of antibiotics in the past 2 years.
- Receipt of any type of live vaccine within 6 months prior to stool donation.
- Their mental health, including depression or other mental illness (their personal mental health and any family history of such conditions).
- History of receiving an experimental medicine (including vaccines)