Status:
UNKNOWN
ProbGut: Probiotics on the Healthy Gut Microbiota
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Mitacs
Conditions:
Healthy
Eligibility:
All Genders
1-3 years
Phase:
NA
Brief Summary
In adults, probiotics have been shown to have no effect on the microbial composition and the beneficial effects are only transient. However, the gut microbiota of young children is less stable and mor...
Detailed Description
Probiotics are live microorganisms that have been associated with health benefits. However, probiotic effects have not been shown to persist beyond discontinuation of use in adults. The intake of prob...
Eligibility Criteria
Inclusion
- Participants will be healthy children between 1 to 3 years of age.
- Participants will be considered healthy on entry into the study if they did not have a history of chronic gastrointestinal issues, including chronic or frequent episodes of diarrhea (\>3 bowel movements/day for 3 consecutive days) during the month prior to enrolment.
- Mother of participant is able to communicate in English (read, write, speak), as she will be required to provide her personal and medical history.
Exclusion
- Lactose or milk protein intolerance, or strawberry anaphylaxis, or allergies to dried citrus pulp, or any other components of the study product.
- Immuno-compromised children (e.g. heart or kidney transplant, complex care, sickle cell disease) or those on immunosuppressive agents (e.g. chemotherapy agents, oral prednisone).
- Children with known or potentially compromised gut integrity (e.g. short gut, Inflammatory Bowel Disease, Celiac, nasogastric, naso-jejunal or gastrostomy tube).
- Children admitted to a medical or surgical subspecialty unit.
- Children on antimicrobial therapy within 30 days prior to enrolment.
- Children on an alternative probiotic within 30 days prior to enrolment.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2018
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03430726
Start Date
March 1 2018
End Date
November 30 2018
Last Update
August 17 2018
Active Locations (1)
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1
McMaster University
Hamilton, Ontario, Canada, L8S 4K1