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

Safety Clinical Trial

— BSSII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568567
• Other study ID #: CSP U-11-008
• Secondary ID: CSUB0031
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 28, 2012
• Last updated: July 3, 2012
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Good Food Practice, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Safety

Intervention

Dietary Supplement:
• Lactobacillus Reuteri DSM 17938
One stick pack in the morning and one stick pack afternoon/evening for 28 days.

Locations

Country	Name	City	State
Sweden	Good Food Practice Uppsala	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Good Food Practice, Sweden	BioGaia AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes