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

NCT ID: NCT01568567

Last Updated: 2012-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-06-30

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.

Detailed Description

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Conditions

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Safety

Keywords

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safety tolerance lactobacillus Reuteri

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Double dose

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

Group Type ACTIVE_COMPARATOR

Lactobacillus Reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

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

Single dose

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

Group Type ACTIVE_COMPARATOR

Lactobacillus Reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Lactobacillus Reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Lactobacillus Reuteri DSM 17938

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

Intervention Type DIETARY_SUPPLEMENT

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role collaborator

Good Food Practice, Sweden

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johan Olsson, PhD

Role: PRINCIPAL_INVESTIGATOR

KPL Good Food Practice AB

Locations

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Good Food Practice Uppsala

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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CSUB0031

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CSP U-11-008

Identifier Type: -

Identifier Source: org_study_id