Status:
COMPLETED
The Impact of Probiotics on Well-being in Women
Lead Sponsor:
Cultech Ltd
Collaborating Sponsors:
Comac Medical
Conditions:
Female
Healthy Aging
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief Summary
An exploratory study to determine whether daily supplementation with a probiotic product impacts the overall well-being of women aged between 45 - 65
Detailed Description
It is generally accepted that there is a gradual decline in general well-being associated with aging. In previous studies with healthy adults receiving the Lab4P probiotic the outcomes indicated an ov...
Eligibility Criteria
Inclusion
- Women aged 45 to 65
- Willing to provide faecal samples, blood samples and vaginal swabs
- BMI of less than 30 kg/m2
- Willing to maintain normal diet and lifestyle during the study
- Willing to refrain from taking other probiotic supplements during the study
- Normal (or corrected-to-normal) vision without colour blindness in order to complete the cognitive task
Exclusion
- No oral antibiotics within the last 3 months
- No previous been involvement in a Cultech funded study
- No regular consumption of probiotics within the last 1 month prior to the study
- Premature menopause (onset before age of 40)
- Given birth in the last 3 months, currently pregnant or planning pregnancy
- Receiving hormone replacement therapy
- Shift worker
- Diagnosed with diabetes
- Immunodeficient or undergoing immunosuppressive therapy
- Diagnosed with arrhythmia, ventricular extrasystole or atrioventricular block
- Diagnosed with a cardiovascular disease
- Diagnosed with a severe systemic disease e.g. cancer, dementia, advanced organ failure.
- Unexplained loss of weight in recent months
Key Trial Info
Start Date :
July 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06507111
Start Date
July 30 2024
End Date
February 5 2025
Last Update
March 21 2025
Active Locations (1)
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1
Comac Medical
Sofia, Bulgaria