Phase 2
Completed N=42
Safety, Tolerability and Host Response to Lactobacillus Johnsonii
Healthy
Source: ClinicalTrials.gov NCT02349360 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Number of Participants Reporting Adverse Events — 1; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Adverse Events |
1; 2 | — |
| SECONDARY Composite Measure of Blood Chemistry Profiles |
0; 0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02349360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.