Safety, Tolerability and Host Response to Lactobacillus Johnsonii (LJ)

May 18, 2018 updated by: University of Florida
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Healthy adult volunteers from 18-50 years of age will be recruited through the University of Florida and randomly distributed into two groups. This study is divided into 3 phases: baseline, intervention (study treatment) and washout. Participants will receive either the probiotic or placebo during the intervention phases. During the baseline phase, blood and fecal samples will be collected about 1 week before intervention initiation. On the day of a scheduled blood draw, the participant will need to arrive fasted overnight, and a light breakfast will be provided after blood draw. Starting on day 1 of the intervention phase, a second baseline blood sample will be collected and the participant will begin the study intervention (probiotic or placebo). Participants will consume 1 capsule (probiotic or placebo) daily for 8 weeks, and blood and stool samples will be collected and processed (on or around weeks 2, 4 and 8 of the intervention phase). A Fisher Scientific commode specimen collection system will be provided for stool collections. The stool collection kit may be taken home (participants will be asked to drop off the stool within 4 hours of defecation) for fecal sample collection or may use the restroom in the clinical lab at the Food Science and Human Nutrition Building in which kits will be provided for use. In the wash-out phase, participants will not consume the capsule (either the probiotic or placebo), but will provide blood and stool samples (on or around week 12). Throughout the study, participants will provide a total of 5 stool samples and 6 blood samples. Participants will be asked to complete daily and weekly questionnaires throughout all phases of the study, which will ask about quality of life (physical functioning, mental functioning, level of sleep, etc.), gastrointestinal function, and dietary intake. These assessments will be self-reported via online questionnaires. In the event that internet access is not available for a portion of the study, paper copies of the questionnaires may be provided.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida, Food Science and Human Nutrition Dept

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks
Biological: L. johnsonii N6.2
L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks
Other Names:
  • Lactobacillus
Placebo Comparator: Placebo
Encapsulated starch placebo administered for 8 weeks
Biological: Placebo
Encapsulated starch placebo administered for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Adverse Events
Time Frame: 13 weeks
The number of participants reporting Adverse Events was reported.
13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Measure of Blood Chemistry Profiles
Time Frame: 13 weeks
Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.
13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

Juvenile Diabetes Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

January 27, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

June 14, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201400370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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