Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Antibiotic Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667653
• Other study ID #: 11PDHD
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2012
• Last updated: August 14, 2012
• Start date: March 2012
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic Therapy

Intervention

Dietary Supplement:
• Probiotic
Probiotic capsule once daily
• Placebo
Placebo capsule once daily

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London/Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Danisco	KGK Synergize Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No