We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01568567
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : July 4, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Safety Dietary Supplement: Lactobacillus Reuteri DSM 17938 Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Safety measured by blood chemistry parameters [ Time Frame: 28 days ]
    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.

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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Good Food Practice, Sweden
ClinicalTrials.gov Identifier: NCT01568567     History of Changes
Other Study ID Numbers: CSP U-11-008
CSUB0031 ( Other Grant/Funding Number: Biogaia AB )
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

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