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

Good Food Practice, Sweden32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Safety

Interventions

Lactobacillus Reuteri DSM 17938

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.