We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Effect of a Lacidofil® STRONG in Healthy Adults Taking 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.
ClinicalTrials.gov Identifier: NCT01941160
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : May 14, 2014
Lallemand Health Solutions
Information provided by (Responsible Party):
Dale Wilson, MD, KGK Science Inc.

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.

Condition or disease Intervention/treatment Phase
Antibiotic Associated Diarrhea Dietary Supplement: Lacidofil® STRONG Dietary Supplement: Placebo Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 :
  1. 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)

  2. 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:
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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 ClinicalTrials.gov identifier (NCT number): NCT01941160

Layout table for location information
Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
Lallemand Health Solutions
Layout table for investigator information
Principal Investigator: Dale Wilson, MD KGK Science Inc.
Layout table for additonal information
Responsible Party: Dale Wilson, MD, Medical Director, KGK Science Inc.
ClinicalTrials.gov Identifier: NCT01941160    
Other Study ID Numbers: 13LAHL
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms, Digestive