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

This study has been completed.
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
Dale Wilson, MD, KGK Synergize Inc.
ClinicalTrials.gov Identifier:
NCT01941160
First received: August 23, 2013
Last updated: May 12, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of AAD [ Time Frame: Up to 63 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941160

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

No publications provided

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014