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Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667653
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : August 17, 2012
KGK Science Inc.
Information provided by (Responsible Party):

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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

Primary Outcome Measures :
  1. Maintenance of intestinal microbiotic composition before, during and after antibiotic treatment with Augmentin 875mg [ Time Frame: 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 [ Time Frame: 3-weeks ]
    Questionaire is used to assess the tolerability of the probiotic supplementation, Bowel habit scores, adverse effects,

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667653

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KGK Synergize Inc.
London/Ontario, Canada
Sponsors and Collaborators
KGK Science Inc.

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Responsible Party: Danisco Identifier: NCT01667653     History of Changes
Other Study ID Numbers: 11PDHD
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: August 17, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents