None
Conditions
Interventions
A:"Reuteri?Probiotics Drop"
5 drops daily for 14 days concomitant with 7 days of Augmentin (1 g bd twice daily). Antibiotic and probiotic are taken orally
B:"NESTLéi? Acti-Vi? Low Fat Yogurt"
1 tube daily for 14 days concomitant with 7 days of Augmentin (1 g bd twice daily). Antibiotic and probiotic are taken orally
C:"Adrien Gagnon Probiotic 7 Billion"
3 capsules daily for 14 days concomitant with 7 days of Augmentin (1 g bd twice daily). Antibiotic and probiotic are taken orally
D:Spontaneous recovery after 7 days of Augmentin (1 g bd twice daily) via oral route. Placebo was also not given due to the potential of affecting the microbiome results
Sponsors
The Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Participated in a previous entitled Modulation of gut microbiota with probiotics: a pilot study (IRB No. 2018.116); 2. Aged 18 to 50 years old (Both male and female); 3. Able to comply with study requirements and to provide informed consent; 4. Agreement to comply with approved methods of contraception during the period of active study.
Exclusion criteria
Exclusion criteria: 1. Any chronic or recurrent illness requiring follow-up or medication; 2. Pregnancy; 3. History of organ transplantation or immunosuppression; 4. A history of allergy or hypersensitivity to the probiotic bacteria, placebo or antimicrobial agent eg. augmentin, amoxicillin-clavulanate, amoxicillin or other penicillins, or cephalosporins; 5. History of any severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnea, wheezing, hypotension, loss of consciousness); 6. Oral or systemic antibacterial/ antifungal or antiviral therapy during the 3 months prior to study enrollment; 7. New prescription medications during the 4 weeks prior to study enrollment; 8. Over-the-counter medications or supplements that are known to alter gut function or microflora (i.e., acid anti-secretory drugs, probiotics, laxatives) during the 4 weeks prior to study enrollment (except articles of the Phase 1 study); 9. Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy); 10. Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol; 11. Current smoker; 12. Regular intake of medication (birth control pills excepted); 13. History of structural heart diseases such as valve abnormality, valve replacement or endocarditis (S. Doron & David R. Snydman, 2015); 14. Patient with a central venous catheter (S. Doron & David R. Snydman, 2015).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitation of probiotic bacteria and their persistence in the gut ;Evaluate the changes in composition of gut microbiota community composition;The restoration of the gut phyla during course of antibiotic with concomitant probiotic in Hong Kong healthy adults; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the abundance and changes of antimicrobial resistance genes ARGs ;The tolerability of the probiotic(s) in subjects taking antibiotic in Hong Kong;The changes to ‘resistome’ in antibiotic use with concomitant use of probiotics; | — |
Countries
China
Contacts
Public ContactMargaret Ip
The Chinese University of Hong Kong
Outcome results
None listed