Clinical trial NCT01941160: Effect of a Lacidofil® STRONG in Healthy Adults Taking Antibiotic Treatment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Antibiotic Associated Diarrhea
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lallemand Health Solutions
First posted: 2013-09-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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).
timeFrame: Up to 63 days
Secondary outcomes:
measure: Incidence of AAD
timeFrame: Up to 63 days
measure: Influence of Lacidofil® STRONG on side effects associated with antibiotic use
timeFrame: Up to 63 days
Other outcomes:
measure: Safety profile of Lacidofil® STRONG
timeFrame: Up to 14 days
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Dale Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: