HealthyPhase 1/2LJNCT02349360
Safety, Tolerability and Host Response to Lactobacillus Johnsonii
A Phase 1/2 study testing L. johnsonii N6.2 in people with Healthy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- L. johnsonii N6.2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida, Food Science and Human Nutrition Dept
Gainesville, Florida, 32611
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- L. johnsonii N6.2, Placebo
- Keywords
- safety, tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. johnsonii N6.2Biological
Also called Lactobacillus
- johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks
PlaceboBiological
Encapsulated starch placebo administered for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks Receives: Biological: L. johnsonii N6.2 |
| Placebo | Placebo comparator | Encapsulated starch placebo administered for 8 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Adverse Events
The number of participants reporting Adverse Events was reported.
Measured: 13 weeks
Secondary outcomes (1)
Composite Measure of Blood Chemistry Profiles
Number of clinically relevant out of range values of the comprehensive metabolic panel and hemogram during intervention through washout period vs baseline.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Wendy J Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349360
- Sponsor's protocol ID
- 201400370
- Acronym
- LJ
- Status last verified
- May 2018
- First submitted
- 2 Jul 2014
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28659913
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Host Response to Lactobacillus Johnsonii
- ClinicalTrials.gov ID
- NCT02349360
- Acronym / sponsor ID
- LJ / 201400370
- Conditions
- Healthy
- Keywords
- safety, tolerability
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Posted 18 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Biological: L. johnsonii N6.2L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks |
| Placebo | Placebo comparator | Biological: PlaceboEncapsulated starch placebo administered for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- To participate in the study individuals must
Key exclusion criteria (7 listed)
- To participate in the study individuals must NOT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L. johnsonii N6.2Also: LactobacillusL. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks | Biological | Probiotic |
| PlaceboEncapsulated starch placebo administered for 8 weeks | Biological | Placebo |
Primary outcome
Number of Participants Reporting Adverse Events
Time frame: 13 weeks
The number of participants reporting Adverse Events was reported.
1 secondary outcome
Composite Measure of Blood Chemistry Profiles
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28659913Marcial 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.
- Lactobacillus johnsonii N6.2 Modulates the Host Immune Responses: A Double-Blind, Randomized Trial in Healthy Adults.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy J Dahl, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing L. johnsonii N6.2 in people with Healthy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Adverse Events (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02349360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2018.