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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01568567

Acronym

BSSII

Enrollment

Registered

2012-04-02

Start date

2012-03-31

Completion date

2012-06-30

Last updated

2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety

Keywords

safety, tolerance, lactobacillus Reuteri

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus Reuteri DSM 17938

One stick pack in the morning and one stick pack afternoon/evening for 28 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety measured by blood chemistry parameters	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.
Tolerability measured by blood chemistry parameters	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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026