Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 1403 for:    Peru

Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02124122
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Johns Hopkins Bloomberg School of Public Health
Asociación Benéfica Prisma
Information provided by (Responsible Party):
Richard A. Oberhelman, Tulane University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Healthy
Interventions Biological: Lactobacillus reuteri
Biological: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lactobacillus Placebo
Hide Arm/Group Description

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

Lactobacillus reuteri: Probiotic

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Placebo: Placebo

Period Title: Overall Study
Started 41 19
Completed 41 19
Not Completed 0 0
Arm/Group Title Lactobacillus Placebo Total
Hide Arm/Group Description

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

Lactobacillus reuteri: Probiotic

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Placebo: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 41 19 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 19 participants 60 participants
4.04  (1.278) 3.31  (1.080) 3.81  (1.258)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 19 participants 60 participants
Female
21
  51.2%
13
  68.4%
34
  56.7%
Male
20
  48.8%
6
  31.6%
26
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 19 participants 60 participants
Hispanic or Latino
41
 100.0%
19
 100.0%
60
 100.0%
Not Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Peru Number Analyzed 41 participants 19 participants 60 participants
41 19 60
1.Primary Outcome
Title Number of Participants With Positive Blood Culture for L Reuteri
Hide Description [Not Specified]
Time Frame Participants are followed an average of 36 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Placebo
Hide Arm/Group Description:

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

Lactobacillus reuteri: Probiotic

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Placebo: Placebo

Overall Number of Participants Analyzed 41 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Mean Daily Temperature
Hide Description Mean of body temperatures recorded on study days listed, averaged across all participants at all time points
Time Frame Study days 1-5, 8,12, 15, 18, 28, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Placebo
Hide Arm/Group Description:

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

Lactobacillus reuteri: Probiotic

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Placebo: Placebo

Overall Number of Participants Analyzed 41 19
Mean (Standard Deviation)
Unit of Measure: Degrees Celsius
36.50  (0.288) 36.45  (0.232)
Time Frame Day 0 through Day 28 after day 0
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lactobacillus Placebo
Hide Arm/Group Description

Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).

Lactobacillus reuteri: Probiotic

Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).

Placebo: Placebo

All-Cause Mortality
Lactobacillus Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lactobacillus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/41 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lactobacillus Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/41 (60.98%)      18/19 (94.74%)    
Gastrointestinal disorders     
Diarrhea  [1]  4/41 (9.76%)  6 7/19 (36.84%)  7
Infections and infestations     
Malaria   1/41 (2.44%)  1 1/19 (5.26%)  1
Scabies   0/41 (0.00%)  0 1/19 (5.26%)  1
Renal and urinary disorders     
Urinary tract infection   3/41 (7.32%)  3 2/19 (10.53%)  2
Respiratory, thoracic and mediastinal disorders     
Upper repiratory infection   23/41 (56.10%)  32 9/19 (47.37%)  14
Pneumonia   1/41 (2.44%)  1 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cellulitis   1/41 (2.44%)  1 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
At least one episode of diarrhea during 28 days of active surveillance
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Oberhelman
Organization: Tulane SPHTM
Phone: 5049882511
EMail: oberhel@tulane.edu
Layout table for additonal information
Responsible Party: Richard A. Oberhelman, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT02124122     History of Changes
Other Study ID Numbers: FDA IND# 13710-Protocol 2
5U01AT002733 ( U.S. NIH Grant/Contract )
First Submitted: April 24, 2014
First Posted: April 28, 2014
Results First Submitted: December 16, 2016
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017