Lactobacillus Johnsonii in Children and Adolescents With T1D
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|ClinicalTrials.gov Identifier: NCT03961854|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 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 with children and adolescents (8-less than 18 years old) with T1D (duration >4 months but <2 years).|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D|
|Estimated Study Start Date :||July 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): NCT03961854
|Contact: Michael Haller, MDfirstname.lastname@example.org|
|Contact: Miriam Cintronemail@example.com|
|United States, Florida|
|UF Clinical Research Center||Not yet recruiting|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Michael Haller||University of Florida|