Microbiome, Probiotic
Conditions
Brief summary
Antibiotic therapy can cause gastrointestinal dysbiosis and this study will assess the impact of probiotic supplementation on microbiological composition and functionality pre- and post- antibiotic therapy
Interventions
DIETARY_SUPPLEMENTLab4S
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Cultech Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Adults, aged 18-40. 2. Been prescribed an oral dose of cephalosporin antibiotic lasting 5 - 10 days. 3. Willing to provide stool samples and, for women, vaginal samples. 4. Willing to avoid consumption of any other probiotic capsules/tablets during the study.
Exclusion criteria
1. If antibiotics prescribed are intended to treat any gastrointestinal or vaginally related issue. 2. Any antibiotic intake within the last 3 months. 3. Immunodeficient or undergoing immunosuppressive therapy. 4. Currently diagnosed with diabetes/cardiovascular disease/cancer/dementia. 5. Any unexplained loss of weight in recent months. 6. Known to be pregnant or \<3 months postpartum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics | From date of randomization until the end of the study (90 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention. | One month post antibiotic treatment/ intervention (30 days) | A daily gastrointestinal/Vaginal health symptom record sheet which involves ticking off symptoms is present. |
| Bowel habit diary to measure gastrointestinal health post Intervention | One month post antibiotic treatment/ intervention (30 days) | A bowel habit diary questionnaire to be completed for every attempted bowel motion during the study. Questions include; 1. Were you able to pass a stool?, 2. Did you feel an urgent need to pass the bowel motion?, 3. Did you strain to start the bowel motion?, 4. Were you left with a feeling of incomplete evacuation?, 5. Please rate the appearance of your bowel motion using the bristol stool score (1-7). |
Countries
Bulgaria
Contacts
CONTACTMaya Dabcheva
Outcome results
None listed