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

Antibiotic Associated Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941160
• Other study ID #: 13LAHL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 23, 2013
• Last updated: May 12, 2014
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2014
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic Associated Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• Lacidofil® STRONG
Lacidofil® STRONG capsule twice daily
• Placebo
Placebo capsule twice daily

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Lallemand Health Solutions

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety profile of Lacidofil® STRONG	Assessed by measurement of biometrics, vital signs, general blood chemistry and complete blood counts	Up to 14 days	No
Primary	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).		Up to 63 days	Yes
Secondary	Incidence of AAD	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)	Up to 63 days	Yes
Secondary	Influence of Lacidofil® STRONG on side effects associated with antibiotic use	Assessed by Gastrointestinal Symptom Rating Scale (GSRS) questionnaire, bowel habits, adverse effects	Up to 63 days	No