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

NCT01941160 | Completed Phase 1

• 1 other identifier: 13LAHL
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Associated Diarrhea

Outcome Measures

Primary Outcomes (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).

  Up to 63 days

Secondary Outcomes (2)

• Incidence of AAD

  Up to 63 days

• Influence of Lacidofil® STRONG on side effects associated with antibiotic use

  Up to 63 days

Other Outcomes (1)

• Safety profile of Lacidofil® STRONG

  Up to 14 days

Study Arms (2)

Amoxicillin/Clavulanic Acid and Lacidofil® STRONG

EXPERIMENTAL

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

Dietary Supplement: Lacidofil® STRONG

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Lacidofil® STRONG DIETARY_SUPPLEMENT

Lacidofil® STRONG capsule twice daily

Amoxicillin/Clavulanic Acid and Lacidofil® STRONG

Placebo DIETARY_SUPPLEMENT

Placebo capsule twice daily

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• Lallemand Health Solutions: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Dale Wilson, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 13, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-03

Locations

CA (1)