Lactobacillus Johnsonii Supplementation in Adults With T1D
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03961347|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes (T1D)||Drug: L. johnsonii Probiotic Drug: Placebo Capsule||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, double-blinded, placebo-controlled clinical trial will be carried out in subjects between 18-45 years old with T1D.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Safety, Tolerability and Immunological Responses to Lactobacillus Johnsonii N6.2 Supplementation in Adults With Diabetes Type 1|
|Estimated Study Start Date :||October 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Active Comparator: Probiotic Group
The probiotic group will receive a daily capsule with Lactobacillus johnsonii N6.2 1x109 CFUs. Participants will consume one capsule (treatment or placebo) daily for 24 weeks.
Drug: L. johnsonii Probiotic
Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
Placebo Comparator: Placebo Group
The placebo group will receive a capsule daily with dried skim milk (vehicle of the probiotic). Participants will consume one capsule (treatment or placebo) daily for 24 weeks.
Drug: Placebo Capsule
Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.
- Number of participants with at least one adverse event [ Time Frame: End of study (48 weeks) ]Adverse events will only include those that are determined to be related to L. johnsonii N6.2 supplementation.
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): NCT03961347
|Contact: Michael Haller, MDemail@example.com|
|Contact: Miriam Cintronfirstname.lastname@example.org|
|United States, Florida|
|UF Clinical Research Center||Not yet recruiting|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Michael Haller||University of Florida|