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

NCT ID: NCT01941160

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Antibiotic Associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Amoxicillin/Clavulanic Acid and Lacidofil® STRONG

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

Group Type: EXPERIMENTAL

Lacidofil® STRONG

Intervention Type: DIETARY_SUPPLEMENT

Lacidofil® STRONG capsule twice daily

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo capsule twice daily

Interventions

Lacidofil® STRONG

Lacidofil® STRONG capsule twice daily

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo capsule twice daily

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lallemand Health Solutions

INDUSTRY

Sponsor Role: collaborator

KGK Science Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Dale Wilson, MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dale Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

KGK Synergize Inc.

London, Ontario, Canada

Countries

Canada

Other Identifiers

13LAHL

Identifier Type: -

Identifier Source: org_study_id