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

G

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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