Safety, Tolerability and Host Response to Lactobacillus Johnsonii

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02349360

Run by

University of Florida

People needed

42

Starts

2015-08-01

Expected to finish

2016-12-01

Last updated by the study team

2018-06-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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