Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Study Overview
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Brief Summary
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This is randomized, double-blind, placebo controlled, single centre; 21 days phase II clinical trial on healthy volunteers. Following baseline visit at the day of randomization, treatment with Augmentin 875mg for 7 days will be given. Concurrently and after antibiotic treatment subjects will also receive the study treatment, either probiotic or placebo. Daily Bowel Habit Diary will be completed by the subjects. The subjects will be asked to collect fecal samples for microbiological examination. The primary objective of the study is to evaluate the maintenance of intestinal microbiota composition during antibiotic treatment with Augmentin 875mg. Secondary objectives will be to evaluate the reduction in side effects associated with antibiotic use.

Official Title
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A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Conditions
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Antibiotic Therapy

Intervention / Treatment
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* Dietary Supplement: Probiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 to 50 years. Healthy as determined by laboratory results, medical history and physical exam Willing to give voluntary, written, informed consent to participate in the study Exclusion Criteria: Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial Body mass index ≥ 30 kg/m2 Average number of formed bowel movements > 3 per day or < 3 per week Smokers Participation in a clinical research trial within 30 days prior to randomization Use of antibiotics within 60 days prior to randomization. Habitual use of pro- and/or prebiotic products. Follows a vegetarian or vegan diet Unstable medical conditions Any evidence of acute or chronic gastrointestinal disorder Alcohol use > 2 standard alcoholic drinks per day and/or alcohol or drug abuse within past year Allergy or sensitivity to test product ingredients or antibiotic Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmentin/Probiotic<br>Participants are provided in double blinded fashion probiotic to take with antibiotics | Dietary Supplement: Probiotic<br>* Probiotic capsule once daily<br>|
| Experimental: Augmentin/placebo<br>Participants are provided in double blinded fashion placebo to take with antibiotics | Dietary Supplement: Placebo<br>* Placebo capsule once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg | Fecal samples collected during the 3 week period and stored frozen until analyses. Bacterial DNA is extracted from the samples and the microbial composition is analysed by molecular methods such as quantitative PCR. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of probiotics on side effects associated with antibiotic use | Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects, | 3-weeks |