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

Study Overview
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Brief Summary
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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.

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

Conditions
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Safety

Intervention / Treatment
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* Dietary Supplement: Lactobacillus Reuteri DSM 17938


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Double dose<br>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<br>* One stick pack in the morning and one stick pack afternoon/evening for 28 days.<br>|
| Active Comparator: Single dose<br>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<br>* One stick pack in the morning and one stick pack afternoon/evening for 28 days.<br>|
| Placebo Comparator: Placebo<br>One stick pack with placebo contains 1.0 g maltodextrin and silicon dioxide | Dietary Supplement: Lactobacillus Reuteri DSM 17938<br>* One stick pack in the morning and one stick pack afternoon/evening for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, tolerance, lactobacillus Reuteri