Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

This study has been completed.
Sponsor:
Collaborator:
KGK Synergize Inc.
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01667653
First received: March 23, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Antibiotic Therapy
Dietary Supplement: Probiotic
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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:
  • The influence of probiotics on side effects associated with antibiotic use [ Time Frame: 3-weeks ] [ Designated as safety issue: No ]
    Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects,


Enrollment: 80
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667653

Locations
Canada
KGK Synergize Inc.
London/Ontario, Canada
Sponsors and Collaborators
Danisco
KGK Synergize Inc.
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01667653     History of Changes
Other Study ID Numbers: 11PDHD
Study First Received: March 23, 2012
Last Updated: August 14, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014