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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02349360
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : May 18, 2018
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Biological: L. johnsonii N6.2 Biological: Placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability and Host Response to Lactobacillus Johnsonii
Study Start Date : August 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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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 Name: Lactobacillus
Placebo Comparator: Placebo
Encapsulated starch placebo administered for 8 weeks
 Biological: Placebo
Encapsulated starch placebo administered for 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Reporting Adverse Events [ Time Frame: 13 weeks ]
    The number of participants reporting Adverse Events was reported.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349360


Locations
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United States, Florida
University of Florida, Food Science and Human Nutrition Dept
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Juvenile Diabetes Research Foundation
Investigators
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Principal Investigator: Wendy J Dahl, PhD University of Florida
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02349360    
Other Study ID Numbers: 201400370
First Posted: January 28, 2015    Key Record Dates
Results First Posted: May 18, 2018
Last Update Posted: June 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
safety
tolerability