Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Therapy
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • London/Ontario, Canada
    • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Augmentin/Probiotic; Participants are provided in double blinded fashion probiotic to take with antibiotics	Dietary supplement: Probiotic; Probiotic capsule once daily
Experimental: Augmentin/placebo; Participants are provided in double blinded fashion placebo to take with antibiotics	Dietary supplement: Placebo; Placebo capsule once daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Danisco
• Collaborators: KGK Science Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): August 17, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 11PDHD