TML-QA-FRM-074-01 Step 1 of 22 4% Document ID Version Title Effective date: TML-QA-FRM-074-01 01 Donor Questionnaire Author:Date: Approver:Date: Page 1 of 22 Thank you for your interest in becoming a donor for our Faecal Microbiota Transplantation (FMT) program. Before You Begin Before proceeding to the health questionnaire, we kindly ask for your consent to collect and process your personal data. The questionnaire will request information about your medical history, lifestyle, and other relevant details. This information is essential for us to determine your health status and eligibility as a donor. Your Privacy Matters We are committed to protecting your personal data in accordance with the UK General Data Protection Regulation (GDPR). All information provided will be kept confidential and used solely for donor screening purposes. For more details on how we handle your data, please review our Privacy Notice. Consent to ProceedBy agreeing to proceed with the questionnaire, you are providing your consent to provide us with your information for use in our donor screening(Required) Yes, I would like to proceed No I have read the privacy policy(Required) I consent to TML.science contacting me. Please see our Privacy Policy to find out more Document ID Version Title Page 2 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire FMT is a new, ground-breaking revival of an ancient method of microscopically repopulating a human gut that is struggling to function normally. Thank you for expressing an interest. Your co-operation in completing this form is the first step to helping other people in life-changing ways.1. Personal / Contact Details:Date(Required) DD slash MM slash YYYY Gender(Required)First Name:(Required)Surname:(Required)Address(Required)Email Address(Required)Telephone Number:(Required)Date of Birth (DD/MM/YYYY):(Required) DD slash MM slash YYYY Country of Birth:(Required)Height (cm):(Required)Weight (Kg):(Required)Ethnicity:(Required)Occupation:(Required)Next of Kin:(Required)TML.science use only - Calculated BMI:2.Is your working environment high risk for transmission of disease and Does your work or volunteering involve handling human or primate brain tissue or handling farm animals?(Required) Yes No If yes, please provide details:3. Does your work involve travel abroad?(Required) Yes No If yes, please provide details: Document ID Version Title Page 3 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire SECTION 1- PHYSICAL ACTIVITY4. Do you exercise or play sports?(Required) Yes No If yes, please specify-Category/Type?5. Sports Level?(Required) Recreational Elite Amateur Semi-Professional Professional Not Applicable 6. On average, how often do you exercise per week?(Required) Not Applicable 1-2x 3-4x 5-7x >7x 7. Are you currently in a sports team or athletic program?(Required) Yes No If yes, please specify-Name8. Do you have any sporting achievements?(Required) Yes No If yes, please specify- achievement-e.g. National Ranking, Title etc.9. Have you ever completed a DEXA scan and/or VO2 max measurement? If yes, please state body fat mass %, VAT mass and/or relative VO2 max(Required) Yes No If yes, please specify Document ID Version Title Page 4 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire SECTION 2- CURRENT GASTROINTESTINAL SYMPTOMS10. Do you follow a healthy, balanced diet with lots of fresh vegetables?(Required) Always Mostly Sometimes Never 11. Do you currently follow any particular diet (tick all that apply)?(Required) None Vegetarian Vegan Pescatarian Ketogenic Atkins Paleo Gluten-Free Other If Other, please specify12. How often do you have a bowel movement?(Required) Daily Every 2 days Every 3 days Irregular 13. Using Bristol Stool Chart, please state your usual Consistency?(Required) Type 1 Type 2 Type 3 Type 4 Type 5 Type 6 Type 7 14. In the past 4 weeks, have you experienced diarrhoea?(Required) Yes No Document ID Version Title Page 5 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 15. In the last 3 months have you consistently (>25% of bowel movements) experienced any of the following? Please tick all that apply(Required) Straining Lumpy or Hard Stools Sensation of incomplete evacuation Sensation of obstruction or blockage None of above 16. In the last 3 months have you consistently (at least 3 days/month) experienced any of the following? Please tick all that apply(Required) Recurrent bloating Recurrent abdominal pain Mucus in the stool Blood in the stool None of above 17. If you ticked abdominal pain in question 16 in the previous question, did you feel any of the following?(Required) Not Applicable Improvement with defecation See a concomitant change in frequency of stool Other If Other, please specify18. Any unusual stool or sickness related symptoms (e.g. fever, vomiting, nausea in the past 4 weeks?(Required) Yes No If yes, please specify19. Have you ever had blood in your stool?(Required) Yes No 20. Have you ever taken laxatives or anti-diarrhoea medication?(Required) Yes No Document ID Version Title Page 6 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire SECTION 3- MEDICAL HISTORY -GI, LIVER, ALLERGIES21. In the past year, have you been diagnosed by a physician with any of the following? (please tick all that apply)(Required) Not Applicable Chronic Constipation Chronic Diarrhoea Helicobacter Pylori Peptic ulcer disease (i.e. stomach ulcer) Chronic Haemorrhoids Other gastrointestinal conditions If Other, please specify22. Have you ever been diagnosed by a doctor with any of the following? (please tick all that apply)(Required) Not Applicable Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, etc.) Irritable bowel syndrome (e.g. IBS-diarrhoea, IBS-constipation, etc.) Chronic liver disease (e.g. non-alcoholic fatty liver disease, primary sclerosing cholangitis, etc.) Celiac Disease Other Intestinal or Liver condition If Other, please specify23. Do you have a first degree relative (parent/sibling/child) with colon cancer?(Required) Yes No 24. Do you have a first degree relative (parent/sibling/child) with inflammatory bowel disease?(Required) Yes No 25. Do you have a first degree relative (parent/sibling/child) with autism spectrum disorder or Asperger's syndrome?(Required) Yes No 26. Are there any other medical conditions in any first-degree relatives (parent/sibling/child)?(Required) Yes No If yes, please provide details: Document ID Version Title Page 7 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 27. Have you been diagnosed with Allergies (please tick all that apply)(Required) Not Applicable Atopic Dermatitis Eczema Seasonal/Pollen Allergy Pet Allergy Food Allergy If Other allergies, please specify28. If you ticked an allergy for Question 27 have you had any symptoms in the last 12 months?(Required) Yes No 29. If you have had symptoms in the last 12 months, have you been on any medication to manage symptoms?(Required) Yes No If yes, please provide details:30. Do you have any systematic autoimmune conditions?(Required) Yes No 31. Do you have any history of atopy? (e.g. asthma, eosinophilic disorders)(Required) Yes No 32. Within the last 8 weeks, have you experienced any of the following respiratory symptoms (select all that apply)?(Required) Not Applicable A long-lasting cough that you have had for more than three weeks Coughing at night for three weeks or more Experienced wheeziness more than once a week at rest or during light physical activity (e.g. chores). Feeling of tightness round the chest at rest or during light physical activity (e.g. chores) Felt out of breath or short of breath at rest or during light physical activity (e.g. chores) Document ID Version Title Page 8 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire SECTION 4- MEDICAL HISTORY -CVD, METABOLIC, NEUROLOGICAL, CANCER33. Have you ever been diagnosed with any of the following conditions? (please tick all that apply)(Required) Not Applicable Diabetes (Type I or II) Metabolic syndrome High Blood Pressure High Cholesterol Obesity Heart Disease (e.g. atherosclerosis, myocardial infarction, congestive heart failure) Other cardio/metabolic condition If yes, please provide details:34. If you reported a condition in the previous question, do you currently take any medication/treatments to manage your condition?(Required) Yes No Not Applicable If yes, please provide details:35. Have you ever been diagnosed with any of the following conditions? (please tick all that apply(Required) Not Applicable Fibromyalgia Chronic Fatigue Syndrome Other chronic pain (please specify) 36. If you reported a condition in the previous question, do you currently take any medication/treatments to manage your condition?(Required) Yes No Not Applicable 37. Have you ever been diagnosed with the following neurological disorders? (please tick all that apply)(Required) Not Applicable Autism Spectrum Disorder (e.g. Asperger's syndrome) Epilepsy Multiple Sclerosis Parkinson Disease Other neurological conditions (please specify) Document ID Version Title Page 9 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 38. If you reported a condition in the previous question, do you currently take any medication/treatments to manage your condition?(Required) Yes No Not Applicable If yes, please provide details:39. Have you ever been diagnosed by a clinician (e.g. physician or psychologist) with any of the following? (please tick all that apply)(Required) Not Applicable Depression Anxiety (e.g. Generalised anxiety disorder) Bipolar disorder Schizophrenia Eating disorder Other (please specify) 40. If you reported a condition in the previous question, do you currently take any medication/treatments to manage your condition in the last 12 months?(Required) Yes No Not Applicable If yes, please provide details:41. Is there any history of mental illness in your immediate family?(Required) Yes No 42. Do you have a medical history of anxiety (Generalized anxiety disorder)?(Required) Yes No Unsure 43. Do you ever experience the following: Feeling nervous, anxious, or on edge(Required) Not at all Several days Over half the days Nearly everyday 44. Do you ever experience the following: Not being able to stop or control worrying(Required) Not at all Several days Over half the days Nearly everyday Document ID Version Title Page 10 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 45. Do you ever experience the following: worrying too much about different things(Required) Not at all Several days Over half the days Nearly everyday 46. Do you ever experience the following: Trouble relaxing(Required) Not at all Several days Over half the days Nearly everyday 47. Do you ever experience the following: Being so restless that it is hard to sit still(Required) Not at all Several days Over half the days Nearly everyday 48. Do you ever experience the following: Becoming easily annoyed or irritable(Required) Not at all Several days Over half the days Nearly everyday 49. Do you ever experience the following: Feeling afraid as if something awful might happen(Required) Not at all Several days Over half the days Nearly everyday 50. Do you have a medical history of depression or frequently feel depressed/or a sense of hopelessness?(Required) Yes No If yes, please provide details:51. Have you been on medical treatment and/or undergone counselling for anxiety in the last 12 months?(Required) Yes No If yes, please provide details: Document ID Version Title Page 11 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 52. Do you have any family history of significant gastrointestinal conditions? (e.g. a history of IBD or colorectal cancer)(Required) Yes No If yes, please provide details:53. Do you have history of polyposis (e.g. adenomatous polyps, seated polyps)?(Required) Yes No If yes, please provide details:54. Do you have/had any other form of cancer?(Required) Yes No If yes, please provide details:SECTION 5- MEDICAL HISTORY -INFECTIONS55. Have you ever been diagnosed with the following infections? (please tick all that apply)(Required) Not Applicable Sexually Transmitted Disease (e.g. Syphilis, Gonorrhoea, Chlamydia, Trichomoniasis) Genital Herpes HPV HIV Hepatitis (A,B,C,D or E) Tuberculosis 56. Have you ever been diagnosed with Lyme’s Disease(Required) Yes No 57. Have you ever had a tick-bite in the last 6 months?(Required) Yes No Document ID Version Title Page 12 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 58. Diagnosed with Creutzfeldt-Jakob disease (CJD) or known exposure to person with CJD?(Required) Yes No 59. Have you got any cold sores, anal fissures, anal ulcers, anal sores or pruritus ani within the past 3 months?(Required) Yes No If yes, please provide details:60. Do you ever get cold sores?(Required) Yes No If yes, please provide details:61. Have you had an antibiotic-resistant infection? (please tick all that apply)(Required) Not Applicable Methicillin-resistant staphylococcus aureus (MRSA) Carbapenem-resistant Enterobacteriaceae (CRE) Extended spectrum beta-lactamase (ESBLs) Vancomycin-resistant enterococcus (VRE) Other (please specify) 62. Have you had any other infection?(Required) Yes No If yes, please provide details:63. Have you got any haemorrhoids, internal or external?(Required) Yes No 64. Do you currently have, or have you ever had tuberculosis?(Required) Yes No Document ID Version Title Page 13 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 65. Do you have any history of Malaria disease?(Required) Yes No 66. Have you tested for Monkey pox ? Or have been close to someone diagnosed with Monkeypox?(Required) Yes No 67. Have you been positive for Covid-19 in the last 8 weeks?(Required) Yes No 68. Have you ever been diagnosed with ‘long Covid’ ?(Required) Yes No 69. Are you being followed by any medical specialists for any conditions at the moment?(Required) Yes No If yes, please provide details:SECTION 6- MEDICAL HISTORY -CLINICAL PROCEDURES70. Have you ever had any major gastrointestinal surgery (e.g. gastric bypass, colonic resection etc)?(Required) Yes No 71. Have you ever had an operation or had to be hospitalised?(Required) Yes No If yes, please provide details:72. Have you ever had to go undergo an endoscopic examination?(Required) Yes No If yes, please provide details: Document ID Version Title Page 14 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 73. Have you ever had colonic irrigation or hydrotherapy treatment?(Required) Yes No If yes, please provide details:74. In the last 12 months, have you received blood/blood product transfusion from outside the UK?(Required) Yes No 75. In the last 12 months, have you been an inpatient for >24h in a hospital abroad?(Required) Yes No 76. Any other medical or surgery history?(Required) Yes No 77. Have you ever had an organ or tissue transplant?(Required) Yes No SECTION 7- MEDICATION HISTORY78. Do you use natural remedies when you can rather than relying on pharmaceutical products?(Required) Yes No 79. Do you take any supplements (e.g. vitamins, herbals, protein etc.)?(Required) Yes No If yes, please provide details:80. Do you currently take any oral or topical medications (prescription or non-prescription, including seasonal medications)?(Required) Yes No If yes, please provide details (name &frequency): Document ID Version Title Page 15 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 81. Do you take any probiotics?(Required) Yes No If yes, please provide details (name &frequency):82. Do you take any immunosuppressive medications (e.g. steroids, glucocorticoids, calcineurin inhibitors, systemic antineoplastic agents, etc.)(Required) Yes No If yes, please provide details (name &frequency):83. In the last 6 months, have you had any oral or topical antibiotics?(Required) Yes No If yes, please provide details (name &frequency):84. In the last 8 weeks, have you had any oral or topical antifungals?(Required) Yes No If yes, please provide details (name &frequency):85. When was the last time you used antibiotics (please provide details)?(Required)86. In the last 6 months, have you had any antiviral (e.g. Tamiflu) ?(Required) Yes No If yes, please provide details (name &frequency): Document ID Version Title Page 16 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 87. Have you had any vaccines?(Required) Yes No If yes, please provide details (Type & approximate date):88. Do you have any history of receiving an experimental medicine or vaccine?(Required) Yes No If yes, please provide details:89. Have you received a live attenuated virus within the last six months?(Required) Yes No 90. Do you have any history of receiving growth hormone from human pituitary glands, insulin from cows, clotting factor concentrates or known risk of prion disease?(Required) Yes No 91. Do you use any recreational or illicit drugs?(Required) Yes No 92. Have you taken any proton inhibitors, statin, immunosuppression or chemotherapy drugs?(Required) Yes No If yes, please provide details:93. Have you ever taken any of these medications? If yes, please indicate which medication and in the box below, state when last taken: (please tick all that apply)(Required) Soriatane (acitretin) Tegison (etretinate) Avodart or Jalyn (dutasteride) Propecia or Proscar (finasteride) Erivedge (vismodegib) None of the above If yes, please provide details and state when was taken: Document ID Version Title Page 17 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 94. Have you ever had infertility treatment?(Required) Yes No 95. Have you received an Anti-D in Ireland between 1 May 1977 & 31 July 1979 or 1 March 1991 & February 1994? (Why? In Ireland during these periods of time, vials of infectious or potentially infectious Anti-D were manufactured and issued resulting in a potentially increased risk of Hepatitis C)(Required) Yes No 96. For Female Donors: Have you had any abnormal pap smear results?(Required) Yes No Not Applicable If yes, please provide details97. For Female Donors : Are you currently pregnant?(Required) Yes No Not Applicable 98. For Female Dpnors: Are you currently breast feeding?(Required) Yes No Not Applicable 99. Is there anything we might have missed regarding your health condition (genetic or acquired) that we should be aware of? If so, please provide details(Required) Yes No Document ID Version Title Page 18 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 100. Have you ever donated blood?(Required) Yes No 101. Have you had a blood transfusion?(Required) Yes No If yes, please provide details:102. Have you ever been refused by the blood donation service?(Required) Yes No If yes, please provide details:103. Do you currently smoke?(Required) Yes No 104. Have you ever smoked?(Required) Yes No If yes, when did you stop smoking and what was your daily average?105. Do you drink alcohol?(Required) Yes No If yes, please indicate the average number of units per week: 1-2 3-4 4+ 106. Do you have any root canal fillings, amalgam (mercury) fillings or other permanent dental fixtures?(Required) Root Canal Filling Amalgam Filling Dental Fixture None of the above 107. Have you had acupuncture within the last 6 months?(Required) Yes No Document ID Version Title Page 19 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 108. Have you had any tattoos within the last 6 months?(Required) Yes No 109. Have you had any needlestick injuries within the last 6 months?(Required) Yes No 110. Do you have any body piercings?(Required) Yes No If yes, where on the body:111. Have you had any body piercing within the last 6 months?(Required) Yes No If yes, where on the body:112. Do you have semi-permanent make up?(Required) Yes No 113. Have you taken part in unprotected sex (outside a primary monogamous relationship), had any kind of STD or participated in homosexual intimate contact in the last 12 months?(Required) Yes No 114. Have you ever been involved in work as a sex worker or used the services of a sex worker?(Required) Yes No 115. Have you had sex with somebody that was diagnosed with HTLV-1 and 2, hepatitis or has had a positive test for infectious disease?(Required) Yes No 116. If known, please indicate by which method you were born (natural birth or C section)?(Required)117. Please provide details of your foreign travel history over the last 2 years. Details of any travel within the last 6 months are particularly important.(Required) Document ID Version Title Page 20 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire 118. Have you had any food poisoning or parasite infection during or after foreign travel?(Required) Yes No 119. In the next 12 months, do you plan on traveling outside of United Kingdom?(Required) Yes No If yes, please specify- country & approximate date of travel:120. Have you ever spent more than 72 hours in prison for any reason? (including volunteering outreach programs, teaching capacity etc.)?(Required) Yes No 121. Have you ever used any intranasal or intravenous drug use outside of hospital settings or medicinal purpose?(Required) Yes No 122. Are there any other lifestyle factors you engage in that could put you at risk for infection?(Required) Yes No If yes, please specify123. Have you been advised that there is a compensation scheme for stool donors?(Required) Yes No 124. Do you understand that compensation payments may be suspended at any time due to unsuitability of donated material?(Required) Yes No 125. Please explain briefly why you are interested in becoming an FMT donor.(Required)126. Please indicate how you discovered the TML.science FMT donor scheme.(Required)Thank you for completing this questionnaire. We will be in touch with you shortly. Document ID Version Title Page 21 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire Justification (N/A if not applicable): Document ID Version Title Page 22 of 22 TML-QA-FRM-074-01 01 Donor Questionnaire Activity Status (Pass/Fail) Signature & Date Production Supervisor/Manager Quality Assurance
