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

Good Food Practice, Sweden

Status and phase: Completed; Phase 2; Phase 1

Conditions: Safety

Treatments: Dietary Supplement: Lactobacillus Reuteri DSM 17938

Study type: Interventional

Funder types: Industry

Identifiers

NCT01568567

CSP U-11-008

CSUB0031 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 3 patient groups, including a placebo group

Double dose

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus Reuteri DSM 17938

Single dose

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus Reuteri DSM 17938

Placebo

Placebo Comparator group

Description:

One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide

Treatment:

Dietary Supplement: Lactobacillus Reuteri DSM 17938