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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01568567

Safety

COMPLETED PHASE1/PHASE2

Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population

NCT01837940

Constipation Diarrhea Indigestion +2 more

COMPLETED PHASE3

Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile

NCT02127814

Antibiotic-associated Diarrhea Clostridium Difficile

COMPLETED NA

Lactobacillus Reuteri DSM17938 in C-Section Infants

NCT03834415

C-section

COMPLETED NA

Probiotic Lactobacillus Reuteri and Oral Microbiota

NCT02311218

Dental Plaque

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo control

Placebo control without probiotics ATCC PTA 4659

Group Type ACTIVE_COMPARATOR

Probiotic strain ATCC PTA 4659

Intervention Type OTHER

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

ATCC PTA 4659 Low dose

Group Type ACTIVE_COMPARATOR

Probiotic strain ATCC PTA 4659

Intervention Type OTHER

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

ATCC PTA 4659 high dose

Group Type ACTIVE_COMPARATOR

Probiotic strain ATCC PTA 4659

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ATCC PTA 4659

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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