NCT02349360

Brief Summary

The purpose of this research study is to determine the effects of the probiotic, Lactobacillus johnsonii N6.2, on safety, gastrointestinal function, wellness, fecal bacteria and blood biomarkers in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_1 healthy

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

First Submitted

Initial submission to the registry

July 2, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 18, 2018

Completed
Last Updated

June 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

July 2, 2014

Results QC Date

December 21, 2017

Last Update Submit

May 18, 2018

Conditions

Healthy

Keywords

safetytolerability

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Adverse Events

    The number of participants reporting Adverse Events was reported.

    13 weeks

Secondary Outcomes (1)

  • Composite Measure of Blood Chemistry Profiles

    13 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks

Biological: L. johnsonii N6.2

Placebo

PLACEBO COMPARATOR

Encapsulated starch placebo administered for 8 weeks

Biological: Placebo

Interventions

L. johnsonii N6.2BIOLOGICAL

L. johnsonii N6.2 10\^10 CFU in capsule form administered for 8 weeks

Also known as: Lactobacillus
Probiotic
PlaceboBIOLOGICAL

Encapsulated starch placebo administered for 8 weeks

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To participate in the study individuals must
  • be 18-50 years old.
  • be willing to complete multiple questionnaires via computer.
  • be willing to take the probiotic or placebo capsule daily for 8 weeks.
  • be willing to provide 1 stool during weeks 0, 2, 4, 8 and 12 of the study.
  • be willing to provide blood samples at weeks -1, 0, 2, 4, 8 and 12 of the study.
  • have daily access to a computer with internet access for the entire 13-wk study.
  • be willing to provide a social security number

You may not qualify if:

  • To participate in the study individuals must NOT
  • currently take medications for constipation, diarrhea or psychological disorders (depression, anxiety, insomnia etc.).
  • have taken antibiotics within the past four weeks prior to randomization.
  • currently take probiotic supplements and do not want to discontinue a minimum of two weeks prior to the study
  • have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), chronic disease like diabetes or kidney disease, immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, transplant patient etc.)
  • currently receive medical treatment for stress induced symptoms/disorders
  • be a current smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida, Food Science and Human Nutrition Dept

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

  • Marcial GE, Ford AL, Haller MJ, Gezan SA, Harrison NA, Cai D, Meyer JL, Perry DJ, Atkinson MA, Wasserfall CH, Garrett T, Gonzalez CF, Brusko TM, Dahl WJ, Lorca GL. Lactobacillus johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults. Front Immunol. 2017 Jun 12;8:655. doi: 10.3389/fimmu.2017.00655. eCollection 2017.

    PMID: 28659913DERIVED

Related Links

MeSH Terms

Interventions

Lacteol

Results Point of Contact

Title
Wendy Dahl Associate Professor
Organization
University of Florida
wdahl@ufl.edu
3522943707

Study Officials

  • Wendy J Dahl, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2014

First Posted

January 28, 2015

Study Start

August 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

June 14, 2018

Results First Posted

May 18, 2018

Record last verified: 2018-05

Locations

US(1)