Clinical trial NCT02349360: Safety, Tolerability and Host Response to Lactobacillus Johnsonii
Official title: Safety, Tolerability and Host Response to Lactobacillus Johnsonii
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: safety
tolerability
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2015-01-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

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

Primary outcomes:
measure: Number of Participants Reporting Adverse Events
timeFrame: 13 weeks
Secondary outcomes:
measure: Composite Measure of Blood Chemistry Profiles
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida, Food Science and Human Nutrition Dept
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.