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

• ClinicalTrials.gov Identifier: NCT01941160
• Recruitment Status: Completed
• First Posted: September 13, 2013
• Last Update Posted: May 14, 2014
• Sponsor: KGK Science Inc.
• Collaborator: Lallemand Health Solutions
• Information provided by (Responsible Party): Dale Wilson, MD, KGK Science Inc.

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Ontario

KGK Synergize Inc.

London, Ontario, Canada, N6A 5R8

Sponsors and Collaborators

KGK Science Inc.

Lallemand Health Solutions

Investigators

• Principal Investigator: Dale Wilson, MD; KGK Science Inc.

More 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
• Last Update Posted: May 14, 2014
• Last Verified: March 2014

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive