Intestinal Microbiota in Health Volunteers: Role in Fecal Microbiota Transfer including Mental Health


The purpose of this project is to assemble a cohort of healthy volunteers for stool donation following Health Canada guidelines to be used for Fecal Microbiota Transfer in recurrent C. difficile infections and in patients with severe depression

Healthy volunteers ages 18 - 45 will go through a screening process that includes questionnaires on health status, travel, nutrition, and medications. Blood and stool samples will also be collected for testing of microbial pathogens.


Currently recruiting participants: Yes

Eligible gender: Male, Female

Eligible ages: 18 to 45

Accepts healthy participants: Yes

Inclusion criteria:

1- Healthy adults between 18 and 45 years of age.
2- Able to provide and sign informed consent.
3- Able to undergo screening using a self-administered questionnaire for risk-associated behaviors, additional more detailed questionnaire, medical assessment and blood, stool and urine testing for transmissible infectious diseases and mental health questionnaires to exclude mental disorders. This screening is in compliance with Health Canada guidance for FMT for recurrent C. difficile infection (26).
4- Able to adhere to fecal transplantation stool collection standard operating procedure.

Exclusion criteria:

a. Due to the evolving COVID-19 epidemic, in accordance to the Health Canada guidance of March 25, 2020, Donors will be screened for recent travel to affected areas which currently affected by the epidemic, now considered world-wide, and with community spread, to be screened for contact with other persons known to be, or suspected to be infected with the virus.
b. Donors will be screened for symptoms including sore throat, cough, fever, shortness of breath, excessive fatigue, myalgias in the time interval since December 1, 2019. Donors with symptoms will be screened by naso-pharingeal swabs for COVID-19, and if positive, excluded from donation.
c. Serologic testing for antibodies to the virus will be conducted prior to donation using kits available from commercial suppliers approved for use in the United States and available for export to Canada
d. Donated stool shall be quarantined for > 8 weeks before use to account for possible infection in the 6 week donation window plus 2 weeks for converting to positive. If negative donations in the 6 week window would be eligible for use.
Medical History (Self-screening questionnaire):
1. History of any type of active cancer in the last 5 years or family history in first degree (blood) relatives of colon cancer
2. History multiple sclerosis, connective tissue disease, metabolic syndrome, chronic pain syndrome, and atopic diseases or family history of autoimmune disease in first degree (blood) relatives
3. History of chronic Gastrointestinal conditions, e.g., Inflammatory bowel disease, Gastrointestinal motility disorder, Diverticular disease, Other chronic symptoms of diarrhea, Episode of acute diarrhea in the last 3 months, Irritable bowel syndrome, Chronic constipation.
4. History of chronic underlying condition (eg. systemic lupus erythematosus, end-stage renal disease)
5. History, family history in first degree (blood) relatives, or current screening symptoms of psychiatric illness including depression, anxiety disorder, post-partum depression, bipolar disorder, schizophrenia.
6. History or signs of chronic sexually transmitted infections, such as genital ulcerative diseases, anogenital herpes, anogenital warts, chancroid or syphilitic lesions.
7. Risk factors for prion-related disease, including: family history of Creutzfeld-Jacob Disease, corneal or dural transplant, or receipt of human-derived pituitary growth factor.
8. History or family history in first degree (blood) relatives of dementia or degenerative neurological disorders of unknown etiology.
9. Diabetes or “pre-diabetes”,
10. Known and current history of blood in stools
11. Any current or previous medical or psychosocial condition or behaviors which in the opinion of the investigator may pose risk to the recipients or the donor.

Medication and Treatment History:
a. Cholestyramine, Probiotic prebiotic, probiotic or antibiotic agent use for medicinal purposes in the 3 months prior to donation
b. Systemic immunosuppressive or biological agents, systemic agents for cancer therapy, esteroids in the preceding 12 months prior to stool donation.
c. Receipt of any type of live vaccine within 3 months prior to stool donation.
d. Receipt of blood transfusion from a country other than Canada in preceding 6 months.

Blood and Stool tests:
1. Infection or colonization with transmissible agents (Confirmed by Blood and stool tests),
Travel and Lifestyle:
1. History of high risk for recent acquisition of HIV, Hepatitis B or Hepatitis C, as determined by the self-screening using a questionnaire of risk-associated behavior
2. Tattoo or body piercing within 6 months of stool donation.
3. History of incarceration within the last 12 months.
4. Travel outside Canada / United State in the past 6 months
5. Travel to areas of the world where diarrheal illnesses are endemic
6. Smoker (cigarette, marijuana, other)
7. Use of recreational drugs
8. Greater than 2 alcoholic beverages per day on a regular basis
1. Overweight at any time during lifetime
2. Waist circumference > 80 cm for women, > 102 cm for men


This study is not currently accepting expressions of interest via the website. Please see contact information below.

Additional information

Contact information

Microbial Health Clinic. Foothills Medical Centre, South Tower 802

Principal investigator:

Thomas John Louie

Clinical trial: