Status:
COMPLETED
The Impact of Probiotic Supplementation on Antibiotic Induced Changes in Gastrointestinal Function And/or Faecal Microbiota Composition
Lead Sponsor:
Cultech Ltd
Collaborating Sponsors:
Comac Medical
Conditions:
Antibiotic Side Effect
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To investigate whether probiotic supplementation during the consumption of oral antibiotics can impact gastrointestinal responses and/or the regrowth of the gut microbiota.
Detailed Description
The human gut (gastrointestinal tract) is home to more than a trillion mostly "friendly bacteria" = the gut microbiota - that support the well-being and health of an individual through a variety of me...
Eligibility Criteria
Inclusion
- Male or female, aged 18-65
- Receiving a 5 to 10 day course of oral antibiotics
- Willing to provide 3 faecal samples over the duration of the study
- Willing to refrain from taking non-GP (general practitioner) prescribed antibiotics
Exclusion
- Consumed regular probiotic supplementation within the last 1 month prior to the study
- Consumed any antibiotic within the last 3 months
- Prescribed antibiotics for a gastrointestinal related issue
- Diagnosed with diabetes
- Are immunodeficient or undergoing immunosuppressive therapy
- Diagnosed with arrhythmia, ventricular extrasystole, atrioventricular block or other cardiovascular disease deemed as a risk by study doctor
- Diagnosed with a cardiovascular disease
- Pregnancy or planning pregnancy
- 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 :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05355571
Start Date
November 18 2022
End Date
January 30 2023
Last Update
September 19 2024
Active Locations (1)
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1
Comac Medical
Sofia, Bulgaria