Status:
COMPLETED
Improving Wellbeing Through the Brain-Gut-Microbiota Axis
Lead Sponsor:
Pontificia Universidad Catolica de Chile
Collaborating Sponsors:
University of Chile
Instituto de Nutrición y Tecnología de los Alimentos
Conditions:
Healthy Lifestyle
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Well-being is a state defined as the optimal psychological functioning and the experience associated with it, integrating physical and subjective factors. It has been suggested that the bidirectional ...
Detailed Description
Within the field of Psychology and Contemplative Sciences, the relationship and interdependence between the brain and body have been one of the most prevalent questions when it comes to understanding ...
Eligibility Criteria
Inclusion
- Healthy adults of ≥ 18 to \& 65 years old of age.
- Able to provide written consent.
- Willing to provide stool samples and complete questionnaires, records, and diaries associated with the study
- Willingness to discontinue consumption of probiotic supplements for the duration of the study.
Exclusion
- Concurrent consumption of probiotics. Subjects will be eligible for participation, however, after a four (4) week wash-out period.
- Known to be pregnant or breastfeeding or planning on becoming pregnant in the next two (2) months.
- Positive pregnancy test in women of childbearing potential.
- Use of antibiotic drugs (e.g., neomycin, rifaximin) within 1 month of the screening visit. The screened participant would be eligible to participate four (4) weeks after completing their course of antibiotics (wash-out period).
- Subject with diabetes or metabolic diseases.
- Subject with depression or psychiatric and neurological diseases.
- Subject with IBS or gastrointestinal diseases.
- Subject with immune disorders or with possible immune-deficient status (e.g. due to surgery).
- Milk or soy allergy.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2022
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04823533
Start Date
March 30 2021
End Date
March 11 2022
Last Update
June 24 2022
Active Locations (1)
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1
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan, Chile, 7790702