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Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment

Primary Purpose

Antibiotic Associated Diarrhea

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Lacidofil® STRONG
Placebo
Sponsored by
KGK Science Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic Associated Diarrhea

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female aged 18 to 50 years inclusive
  • Body mass index 18.0 - 29.9 kg/m2
  • Healthy as determined by laboratory results, medical history and physical exam
  • Agrees to comply with study procedures
  • Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics) and activity/training levels during the course of the study
  • Has given 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
  • 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. Subjects must not consume foods or supplements containing added pro- and/or prebiotics within 3 weeks prior to randomization and during the course of the study
  • Use of laxatives, enemas or suppositories 1 week prior to randomization and for the duration of the study
  • Follows a vegetarian or vegan diet
  • Unstable medical conditions, as determined by the Qualified Investigator
  • History of chronic gastrointestinal disorders including irritable bowel syndrome; chronic constipation; chronic diarrhea; dyspepsia; gastroesophageal reflux disease; diverticulitis; colitis; Crohn's disease; or any other malabsorption or gastrointestinal disorder
  • Subjects with an immuno-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment)
  • 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 Amoxicillin/Clavulanic Acid
  • Individuals who are cognitively impaired and/or who are unable to give informed consent
  • 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

Sites / Locations

  • KGK Synergize Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxicillin/Clavulanic Acid and Lacidofil® STRONG

Placebo

Arm Description

Participants are provided in double blinded fashion Lacidofil® STRONG to take with antibiotics

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

Outcomes

Primary Outcome Measures

The primary outcomes are the between group difference in mean Bristol Stool Scores (consistency) and the between group difference in the mean number of bowel movements (frequency).

Secondary Outcome Measures

Incidence of AAD
Proportion of subjects having diarrhea-like defecation defined as a stool frequency ≥ 3 per a 24 h period and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days (48 h period)
Influence of Lacidofil® STRONG on side effects associated with antibiotic use
Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects

Full Information

First Posted
August 23, 2013
Last Updated
May 12, 2014
Sponsor
KGK Science Inc.
Collaborators
Lallemand Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01941160
Brief Title
Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment
Official Title
A Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of a Probiotic Product, Lacidofil® STRONG, in Healthy Adults Taking Antibiotic Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KGK Science Inc.
Collaborators
Lallemand Health Solutions

4. Oversight

5. Study Description

Brief Summary
The objectives of this study are to evaluate stool consistency and stool frequency during and up to 8 weeks following a 7 day antibiotic treatment with Amoxicillin/Clavulanic Acid 875mg BID.
Detailed Description
It is hypothesized that the proportion of subjects having a diarrhea-like defecation, defined as a stool frequency ≥ 3 per day and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days will be lower in the group receiving Lacidofil® STRONG compared to the group receiving placebo and therefore mean Bristol Stool Scores will be lower in subjects receiving Lacidofil® STRONG compared to those receiving placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Associated Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Amoxicillin/Clavulanic Acid and Lacidofil® STRONG
Arm Type
Experimental
Arm Description
Participants are provided in double blinded fashion Lacidofil® STRONG to take with antibiotics
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants are provided in double blinded fashion placebo to take with antibiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Lacidofil® STRONG
Intervention Description
Lacidofil® STRONG capsule twice daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule twice daily
Primary Outcome Measure Information:
Title
The primary outcomes are the between group difference in mean Bristol Stool Scores (consistency) and the between group difference in the mean number of bowel movements (frequency).
Time Frame
Up to 63 days
Secondary Outcome Measure Information:
Title
Incidence of AAD
Description
Proportion of subjects having diarrhea-like defecation defined as a stool frequency ≥ 3 per a 24 h period and/or stool consistency ≥ 5 (Bristol Stool Score) for at least 2 days (48 h period)
Time Frame
Up to 63 days
Title
Influence of Lacidofil® STRONG on side effects associated with antibiotic use
Description
Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects
Time Frame
Up to 63 days
Other Pre-specified Outcome Measures:
Title
Safety profile of Lacidofil® STRONG
Description
Assessed by measurement of biometrics, vital signs, general blood chemistry and complete blood counts
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 to 50 years inclusive Body mass index 18.0 - 29.9 kg/m2 Healthy as determined by laboratory results, medical history and physical exam Agrees to comply with study procedures Agrees not to change current dietary habits (with the exception of avoiding pro- and prebiotics) and activity/training levels during the course of the study Has given 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 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. Subjects must not consume foods or supplements containing added pro- and/or prebiotics within 3 weeks prior to randomization and during the course of the study Use of laxatives, enemas or suppositories 1 week prior to randomization and for the duration of the study Follows a vegetarian or vegan diet Unstable medical conditions, as determined by the Qualified Investigator History of chronic gastrointestinal disorders including irritable bowel syndrome; chronic constipation; chronic diarrhea; dyspepsia; gastroesophageal reflux disease; diverticulitis; colitis; Crohn's disease; or any other malabsorption or gastrointestinal disorder Subjects with an immuno-compromised condition (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment) 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 Amoxicillin/Clavulanic Acid Individuals who are cognitively impaired and/or who are unable to give informed consent 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Wilson, MD
Organizational Affiliation
KGK Science Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Synergize Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada

12. IPD Sharing Statement

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Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment

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