Antibiotic Therapy
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic capsule once daily
DIETARY_SUPPLEMENTPlacebo
Placebo capsule once daily
Sponsors
KGK Science Inc.
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg | 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The influence of probiotics on side effects associated with antibiotic use | 3-weeks | Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects, |
Countries
Canada
Outcome results
None listed