Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Phase 2

Completed

• Conditions: Antibiotic Therapy
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT01667653
• Lead Sponsor: Danisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-23
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-17
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Augmentin/Probiotic	Probiotic	Participants are provided in double blinded fashion probiotic to take with antibiotics
Augmentin/placebo	Placebo	Participants are provided in double blinded fashion placebo to take with antibiotics

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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,

Trial Locations

Locations (1)

KGK Synergize Inc.; 🇨🇦 London/Ontario, Canada