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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.
It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amoxicillin/Clavulanic Acid and Lacidofil® STRONG | Experimental | Participants are provided in double blinded fashion Lacidofil® STRONG to take with antibiotics |
|
| Placebo | Placebo Comparator | Participants are provided in double blinded fashion placebo to take with antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacidofil® STRONG | Dietary Supplement | Lacidofil® STRONG capsule twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcomes are the between group difference in mean Bristol Stool Scores (consistency) and the between group difference in the mean number of bowel movements (frequency). | Up to 63 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AAD | Proportion of subjects having diarrhea-like defecation defined as a stool frequency ≥ 3 per a 24 h period and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days (48 h period) | Up to 63 days |
| Influence of Lacidofil® STRONG on side effects associated with antibiotic use |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of Lacidofil® STRONG | Assessed by measurement of biometrics, vital signs, general blood chemistry and complete blood counts | Up to 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale Wilson, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
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| Placebo | Dietary Supplement | Placebo capsule twice daily |
|
Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects |
| Up to 63 days |