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

This study has been completed.
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Good Food Practice, Sweden
ClinicalTrials.gov Identifier:
NCT01568567
First received: March 28, 2012
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Safety
 Dietary Supplement: Lactobacillus Reuteri DSM 17938
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: To Demonstrate That a Novel Powder Formulation of Lactobacillus Reuteri DSM 17938 is Safe in Adults, a Randomized, Placebo Controlled Double-blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Good Food Practice, Sweden:

Primary Outcome Measures:
  • Safety measured by blood chemistry parameters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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.

  • Tolerability measured by blood chemistry parameters [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    To assess tolerability of a novel formulation containing Lactobacillus reuteri DSM 17938 by measuring blood chemistry parameters before and after 28 days of supplementation.


Enrollment: 32
Study Start Date: March 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568567

Locations
Sweden
Good Food Practice Uppsala
Uppsala, Sweden, 751 83
Sponsors and Collaborators
Good Food Practice, Sweden
BioGaia AB
Investigators
Principal Investigator: Johan Olsson, PhD KPL Good Food Practice AB
  More Information

No publications provided

Responsible Party: Good Food Practice, Sweden
ClinicalTrials.gov Identifier: NCT01568567     History of Changes
Other Study ID Numbers: CSP U-11-008, CSUB0031
Study First Received: March 28, 2012
Last Updated: July 3, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Good Food Practice, Sweden:
safety
tolerance
lactobacillus Reuteri

ClinicalTrials.gov processed this record on June 18, 2013