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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab4S | Dietary Supplement | Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention. | A daily gastrointestinal/Vaginal health symptom record sheet which involves ticking off symptoms is present. | One month post antibiotic treatment/ intervention (30 days) |
| Bowel habit diary to measure gastrointestinal health post Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Dabcheva | Contact | +359887113036 | maya.dabcheva@comac-medical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comac Medical | Sofia | Bulgaria |
|
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| Placebo | Dietary Supplement | Placebo |
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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). |
| One month post antibiotic treatment/ intervention (30 days) |