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

This study has been completed.
Lallemand Health Solutions
Information provided by (Responsible Party):
Dale Wilson, MD, KGK Synergize Inc. Identifier:
First received: August 23, 2013
Last updated: May 12, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Antibiotic Associated Diarrhea
Dietary Supplement: Lacidofil® STRONG
Dietary Supplement: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by KGK Synergize Inc.:

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). [ Time Frame: Up to 63 days ]

Secondary Outcome Measures:
  • Incidence of AAD [ Time Frame: Up to 63 days ]
    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 [ Time Frame: Up to 63 days ]
    Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects

Other Outcome Measures:
  • Safety profile of Lacidofil® STRONG [ Time Frame: Up to 14 days ]
    Assessed by measurement of biometrics, vital signs, general blood chemistry and complete blood counts

Enrollment: 160
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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 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
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Please refer to this study by its identifier: NCT01941160

Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Synergize Inc.
Lallemand Health Solutions
Principal Investigator: Dale Wilson, MD KGK Synergize Inc.
  More Information

Responsible Party: Dale Wilson, MD, Medical Director, KGK Synergize Inc. Identifier: NCT01941160     History of Changes
Other Study ID Numbers: 13LAHL
Study First Received: August 23, 2013
Last Updated: May 12, 2014

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents processed this record on May 25, 2017