- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02460575
Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months (PRIDEC Peru)
L. Reuteri for Pediatric Diarrhea in Peru: Growth, Enteropathy, and Microbiota
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a single center Phase 1 double blind placebo controlled trial of Lactobacillus reuteri DSM 17938 in children aged 2-24 months. The study population is based in a community with a registered clinical trial center in rural Peru where this protocol can be done in a highly controlled setting. The study is intended to enroll healthy children living in a resource constrained setting where chronic undernutrition and diarrheal disease is common, as this is the population that is most likely to receive benefit from the use of this and or other probiotic products for the treatment of acute infectious diarrhea and environmental enteropathy.
Up to 100 subjects will be enrolled in order to obtain the randomization of 60 subjects, who will receive study product or placebo at a ratio of 2:1. Participants will be enrolled between the ages of 8 weeks and 24 months. There will be no age stratification. Participants will be screened with a baseline history and physical examination and laboratory tests to determine the HIV status of the child, as well baseline laboratory tests to evaluate occult infections, hepatic function, and renal function. Upon randomization subjects will be screened and randomized to a treatment arm. Product will be administered under the direct supervision of study staff daily for 5 days. The primary outcome is the safety and tolerability of the product at this dose and formulation. Safety will be assessed by the monitoring of baseline laboratory tests at 5 and 28 days following the initiation of therapy and by AE monitoring. Tolerability will be evaluated by analyzing 28 day diary cards that are distributed to all randomized subjects on which parents record their child's symptoms (specifically fever, anorexia/oral intake, vomiting, diarrhea, irritability, rash, wheezing, or open fields which allows them to describe any issue their child may experience and grade its severity) . Secondary outcomes include:
1) The assessment of the duration of shedding of Lactobacillus reuteri (Lr) strain DSM 17938 following administration. This will be determined by and endpoint PCR assay for L. reuteri done on stool collected on D3, D5, D12, D15, D18, D24, D28, D36 on all participants.
The planned enrollment period is four months and the participation of individual subjects is for 3 months. The study should be completed in 7 months. Safety monitoring by treatment group, i.e., infants assigned to active or placebo study product will be conducted by NIDDK appointed DSMB under the direction of the NIDDK Program Official.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Loreto
-
Santa Clara, Loreto, Peru
- Centro de Salud de Santa Clara
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Have a parental permission form signed by both parents
- Be between 8 weeks to 24 months of age with no preexisting exclusion criteria
- Have parents who are willing to comply with all planned study procedures and be available for planned study visits for 3 months.
Exclusion Criteria:
1) No enrollment of family members in households where any of the following are present:
- Another study participant in the household
- Presence of immune suppressed individuals or use of immunosuppressive agents (including but not limited to corticosteroids, methotrexate, etc.) by any household member
Presence of a serious congenital anomaly or chronic medical condition that in the opinion of the investigators would contraindicate participation in any household member, including history of gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy, or abnormal bowel functionality
The following risk factors are at the level of the individual child:
2) Allergy to penicillin, cephalosporins, clindamycin or gentamicin 3) History of antibiotic use in the last 30 days 4) Use of probiotic products within the past 30 days, including masato (local product with fermenting bacteria) and yogurt products containing live bacterial cultures.
5) History of diarrheal illness within the past 30 days (See definition in Protocol Appendix B) 6) Presence of fever or a pre-existing adverse event monitored in the study (See Protocol Appendix B Definitions of AEs for specific adverse events monitored in the study) 7) Positive results on serum diagnostic tests for antibodies to HIV.
8) Presence of severe anemia, defined as serum hemoglobin < 7 gm/dL
9) Out of range laboratory values for total leucocyte count, BUN, Creatinine, AST, ALT, and total bilirubin monitored as potential adverse events, as described in Appendix E.
10) Pre-enrollment stool sample (collected within 14 days of day 1 of the study) is positive for L. reuteri by PCR.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Lactobacillus
Active Product: Description Lactobacillus reuteri 17938 suspended in sunflower oil, medium chain triglyceride oil, silicone dioxide.
Total viable count of L. reuteri 17938 1 x 108 CFU/5 drops.
|
probiotic
|
PLACEBO_COMPARATOR: Placebo
Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide.
Total viable count of L. reuteri is zero CFU/ 5 drops.
|
Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide.
Total viable count of L. reuteri is zero CFU/ 5 drops.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Positive Blood Culture for L. Reuteri
Time Frame: Participants are followed for an average of 36 days
|
number of participants with positive blood culture for L. reuteri
|
Participants are followed for an average of 36 days
|
Mean Daily Temperature
Time Frame: 5 days of study product administration
|
5 days of study product administration
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Margaret N Kosek, MD, University of Virginia
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- U01DK105849 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Lactobacillus reuteri 17938
-
Medical University of WarsawCompletedGastroenteritis | Diarrhea | Nosocomial InfectionPoland
-
Vastra Gotaland RegionCompletedInsulin Resistance | Type 2 DiabetesSweden
-
Medical University of WarsawCompleted
-
Örebro University, SwedenBioGaia ABCompletedAbdominal Pain | Constipation | Diarrhea | Reflux | IndigestionSweden
-
Szpital im. Św. Jadwigi ŚląskiejCompletedAcute GastroenteritisPoland
-
Hospital General Naval de Alta Especialidad - Escuela...Unknown
-
Children's Memorial Health Institute, PolandUnknown
-
Medical University of WarsawCompleted
-
Children's Hospital and Institute of Child Health...UnknownSepsis | Necrotizing Enterocolitis
-
Good Food Practice, SwedenBioGaia ABCompleted