Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

NCT ID: NCT01667653

Last Updated: 2012-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-08-31

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.

Conditions

Antibiotic Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Augmentin/Probiotic

Participants are provided in double blinded fashion probiotic to take with antibiotics

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic capsule once daily

Augmentin/placebo

Participants are provided in double blinded fashion placebo to take with antibiotics

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule once daily

Interventions

Probiotic

Probiotic capsule once daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsule once daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

Danisco

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

KGK Synergize Inc.

London/Ontario, , Canada

Countries

Canada

Other Identifiers

11PDHD

Identifier Type: -

Identifier Source: org_study_id