To Demonstrate That Lactobacillus Reuteri ATCC PTA 4659 Survives Passage Through the Gastrointestinal Tract of Humans

Good Food Practice, Sweden

Status: Completed

Conditions: Recovery of Lactobacillus Reuteri ATCC PTA 4659; The Safety of Lactobacillus Reuteri ATCC PTA 4659

Treatments: Other: Probiotic strain ATCC PTA 4659

Study type: Interventional

Funder types: Industry

Identifiers

NCT01033539

CSP U-08-008 BSS

Details and patient eligibility

About

The purpose of this study is to determine the effects of a sachet containing Lactobacillus Reuteri ATCC PTA 4659 on the recovery of live Lactobacillus reuteri in fecal samples after 7, 14 and 28 days supplementation as well as 14 days wash out compared to the same sachet without the probiotic bacteria as placebo control.

Full description

This study is the first to investigate the relative colonisation of the human GI tract by L Reuteri ATCC PTA 4659. Simple demonstration that they survive passage is the first step in development of potential new probiotics, which is necessary before these strains can be considered for continued testing in probiotic food matrices. The aim of this study will evaluate the safety and tolerability of Lactobacillus Reuteri in healthy adult subjects.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females
• Age 18-65 years
• BMI 19-33
• Hb 120 g/women 130 g/l for men
• Healthy assessed by screening tests and physical examination
• Signed informed consent and bio bank consent

Exclusion criteria

• Participation in a clinical study within 90 days prior screening use of antibiotics 2 weeks before baseline
• Pregnant or lactating

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Placebo control

Active Comparator group

Description:

Placebo control without probiotics ATCC PTA 4659

Treatment:

Other: Probiotic strain ATCC PTA 4659

ATCC PTA 4659 Low dose

Active Comparator group

Treatment:

Other: Probiotic strain ATCC PTA 4659

ATCC PTA 4659 high dose

Active Comparator group

Treatment:

Other: Probiotic strain ATCC PTA 4659