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

A Randomized, Placebo Controlled, Parallel Group Study to Evaluate the Effect of a Probiotic Product, Lacidofil® STRONG, in Healthy Adults Taking Antibiotic Treatment

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Associated Diarrhea
• Intervention / Treatment: Dietary supplement: Lacidofil® STRONG; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amoxicillin/Clavulanic Acid and Lacidofil® STRONG; Participants are provided in double blinded fashion Lacidofil® STRONG to take with antibiotics	Dietary supplement: Lacidofil® STRONG; Lacidofil® STRONG capsule twice daily
Placebo Comparator: Placebo; Participants are provided in double blinded fashion placebo to take with antibiotics	Dietary supplement: Placebo; Placebo capsule twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	Up to 63 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 63 days
Influence of Lacidofil® STRONG on side effects associated with antibiotic use	Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects	Up to 63 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile of Lacidofil® STRONG	Assessed by measurement of biometrics, vital signs, general blood chemistry and complete blood counts	Up to 14 days

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Lallemand Health Solutions

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: 13LAHL