Study to Demonstrate the Safety of a Novel Powder Formulation of Lactobacilli in Adults (BSSII)

To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study

Lactobacilli are commensal bacteria common to the gut of all mammals studied and traditionally associated with foods are considered safe.The established safe use on a diversity of foods and supplement products worldwide supports this conclusion. Lactobacillus reuteri is one species of Lactobacillus that naturally inhabits the gastrointestinal tract of humans and is one of the few autochthonous (indigenous) Lactobacillus species in infants as well as adults.

Although the tolerability of DSM 17938 in a tablet formulation has earlier been established, it is desirable to repeat the assessment in this novel formulation.

Study Overview

• Status: Completed
• Conditions: Safety
• Intervention / Treatment: Dietary supplement: Lactobacillus Reuteri DSM 17938

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 751 83
    • Good Food Practice Uppsala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females
• Age 18-65 years at visit 1
• BMI 19-29
• Hb ≥ 120 g/l for women and ≥ 130 g/l for men
• Healthy as assessed by the screening laboratory tests and blood pressure determined by the MD
• Signed informed consent and biobank consent

Exclusion Criteria:

• Participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
• Use of oral antibiotics or probiotics during 2 weeks prior to visit 1. Other probiotics other than the study products are not allowed during the study period.
• Pregnant or lactating or wish to become pregnant during the period of the study.
• Lack of suitability for participation in the trial, for any reason, as judged by the personnel at Good Food Practice AB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Double dose; One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide	Dietary supplement: Lactobacillus Reuteri DSM 17938; One stick pack in the morning and one stick pack afternoon/evening for 28 days.
Active Comparator: Single dose; One stick pack with active ingredients contains 1.0 g contains 75% GOS (galactooligosaccharide), 25% L-Rhamnose, 1x108 live bacteria (CFU) Lactobacillus reuteri and silicon dioxide	Dietary supplement: Lactobacillus Reuteri DSM 17938; One stick pack in the morning and one stick pack afternoon/evening for 28 days.
Placebo Comparator: Placebo; One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide	Dietary supplement: Lactobacillus Reuteri DSM 17938; One stick pack in the morning and one stick pack afternoon/evening for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety measured by blood chemistry parameters	To assess the safety of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.	28 days
Tolerability measured by blood chemistry parameters	To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.	28 days

Collaborators and Investigators

• Sponsor: Good Food Practice, Sweden
• Collaborators: BioGaia AB
• Investigators: Principal Investigator: Johan Olsson, PhD, KPL Good Food Practice AB

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 28, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): July 4, 2012
• Last Update Submitted That Met QC Criteria: July 3, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: safety; tolerance; lactobacillus Reuteri
• Other Study ID Numbers: CSP U-11-008; CSUB0031 (Other Grant/Funding Number: Biogaia AB)