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Completed

NCT Number: NCT01667653

Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

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.

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Key information

Conditions

Antibiotic Therapy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

KGK Synergize Inc.

London/Ontario, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Probiotic capsule once daily

Placebo

Dietary Supplement

Placebo capsule once daily

Primary outcomes

  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 outcomes

  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,

Sponsors and collaborators

Lead sponsor

Danisco

Industry

Collaborators

  • KGK Science Inc.

Registry information

Official study title

A Randomized Parallel Group Study to Evaluate the Effect of a Probiotic Product in Healthy Adults Undergoing Antibiotic Treatment

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 17, 2012
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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