Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

NCT01667653 | Completed Phase 2

• 1 other identifier: 11PDHD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The influence of probiotics on side effects associated with antibiotic use

  3-weeks

Study Arms (2)

Augmentin/Probiotic

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Augmentin/placebo

EXPERIMENTAL

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

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic capsule once daily

Augmentin/Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo capsule once daily

Augmentin/placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danisco: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London/Ontario, Canada

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: August 17, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

CA (1)