NCT01033539

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

December 15, 2009

Last Update Submit

March 28, 2012

Conditions

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

Keywords

Survivesafetylactobacillus Reuteri

Outcome Measures

Primary Outcomes (1)

  • Change form baseline to day 28 on treatment in level of live Lactobacillus Reuteri ATC PTA 4659 in faecal material.

    Nov 2009-April2010

Study Arms (3)

Placebo control

ACTIVE COMPARATOR

Placebo control without probiotics ATCC PTA 4659

Other: Probiotic strain ATCC PTA 4659

ATCC PTA 4659 Low dose

ACTIVE COMPARATOR
Other: Probiotic strain ATCC PTA 4659

ATCC PTA 4659 high dose

ACTIVE COMPARATOR
Other: Probiotic strain ATCC PTA 4659

Interventions

Probiotic strain ATCC PTA 4659OTHER

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

Also known as: ATCC PTA 4659
ATCC PTA 4659 Low doseATCC PTA 4659 high dosePlacebo control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Good Food Practice

Uppsala, Uppsala County, 751 83, Sweden

Location

Related Publications (1)

  • Sendelius M, Axelsson J, Liu P, Roos S. Genomic, phenotypic, and clinical safety of Limosilactobacillus reuteri ATCC PTA 4659. J Ind Microbiol Biotechnol. 2023 Feb 17;50(1):kuad041. doi: 10.1093/jimb/kuad041.

    PMID: 37974056DERIVED

Study Officials

  • Birgitta E Sundberg, PhD

    Good Food Practice, Uppsala, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2010

Study Completion

August 1, 2011

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations

SE(1)