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

Recovery of Lactobacillus Reuteri ATCC PTA 4659 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033539
• Other study ID #: CSP U-08-008 BSS
• Status: Completed
• Phase: N/A
• First received: December 15, 2009
• Last updated: March 28, 2012
• Start date: November 2009
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Good Food Practice, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Recovery of Lactobacillus Reuteri ATCC PTA 4659
• The Safety of Lactobacillus Reuteri ATCC PTA 4659

Intervention

Other:
• Probiotic strain ATCC PTA 4659
Placebo control containing no probiotic strain of ATCC PTA 4659 High dose of ATCC PTA 4659 1*10 10 CFU/bag Low dose of ATCC PTA 4659 1*10 8 CFU/bag

Locations

Country	Name	City	State
Sweden	Good Food Practice	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Good Food Practice, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.		Nov 2009-April2010	Yes