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Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Sponsor
Danisco (Industry)
Overall Status
Completed
CT.gov ID
NCT01667653
Collaborator
KGK Science Inc. (Industry)
80
Enrollment
1
Location
2
Arms
5
Duration (Months)
15.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Probiotic
  • Dietary Supplement: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment
Study Start Date :
Mar 1, 2012
Actual Primary Completion Date :
Aug 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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,

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KGK Synergize Inc. London/Ontario Canada

Sponsors and Collaborators

  • Danisco
  • KGK Science Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Danisco
ClinicalTrials.gov Identifier:
NCT01667653
Other Study ID Numbers:
  • 11PDHD
First Posted:
Aug 17, 2012
Last Update Posted:
Aug 17, 2012
Last Verified:
Aug 1, 2012

Study Results

No Results Posted as of Aug 17, 2012