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Safety of Lactobacillus Reuteri in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00774163
Recruitment Status : Completed
First Posted : October 17, 2008
Results First Posted : July 12, 2013
Last Update Posted : December 19, 2016
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
Other: Placebo
Enrollment 45
Recruitment Details Potential subjects were inoformed of the study in community meetings in Santa Clara, Peru. Interested individuals were enrolled at the study clinic between Feb. 23, 2010 and April 2, 2010.
Pre-assignment Details  
Arm/Group Title Lactobacillus Group Placebo Group
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 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
Period Title: Overall Study
Started 30 15
Completed 30 15
Not Completed 0 0
Arm/Group Title Lactobacillus Group Placebo Group 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 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 Total of all reporting groups
Overall Number of Baseline Participants 30 15 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 15 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
15
 100.0%
45
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 15 participants 45 participants
39.1  (2.0) 32.3  (2.3) 36.8  (1.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 15 participants 45 participants
Female
23
  76.7%
9
  60.0%
32
  71.1%
Male
7
  23.3%
6
  40.0%
13
  28.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Peru Number Analyzed 30 participants 15 participants 45 participants
30 15 45
1.Primary Outcome
Title Number of Participants With a Positive Blood Culture for L. Reuteri
Hide Description To assess association between administration of Lactobacillus reuteri (Lr) strain DSM 17938 and abnormal lab values (CBC, BUN, Creatinine, AST, ALT, blood culture).
Time Frame participants were followed for an average of 36 days
Hide Outcome Measure Data
Hide Analysis Population Description
2:1 randomization Lactbacillus:placebo using a randomizatin table as specified in the protocol
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Measure Type: Number
Unit of Measure: participants
0 0
2.Primary Outcome
Title Mean Daily Temperature
Hide Description Measured daily during 5 days of study product administration
Time Frame 5 days of study product administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: Degrees Celcius
36.02  (0.5) 36.04  (0.5)
3.Primary Outcome
Title Leukocyte Count on Day 5
Hide Description [Not Specified]
Time Frame Measured on day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter
6936  (1331) 7893  (1168)
4.Primary Outcome
Title Serum Alanine Aminotransferase (ALT) in Female Participants
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
limited to females
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 23 9
Mean (Standard Deviation)
Unit of Measure: units per liter (U/L)
30.3  (18.0) 22.2  (12.4)
5.Primary Outcome
Title Serum ALT in Males
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
limited to males
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: units per liter (U/L)
31.1  (29.7) 27.8  (10.4)
6.Primary Outcome
Title Serum Aspartate Aminotransferase (AST) in Females
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
limited to females
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 23 9
Mean (Standard Deviation)
Unit of Measure: units per liter (U/L)
28.3  (13) 22.4  (5.1)
7.Primary Outcome
Title Serum AST in Males
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
limited to males
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: units per liter (U/L)
31  (16.1) 31  (16.9)
8.Primary Outcome
Title Blood Urea Nitrogen
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: mg/dl
22.4  (7.0) 19.3  (5.4)
9.Primary Outcome
Title Serum Creatinine
Hide Description [Not Specified]
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.73  (0.16) 0.73  (0.24)
10.Secondary Outcome
Title Number of Subjects With at Least One PCR Positive Stool Specimen
Hide Description [Not Specified]
Time Frame Average of 36 day follow up period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Measure Type: Number
Unit of Measure: participants
9 5
11.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Vomiting Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
4 3
12.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Pruritis Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
1 12
13.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Headache Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
67 32
14.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Malaise Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
13 19
15.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Diarrhea Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
18 5
16.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Myalgia Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
41 15
17.Secondary Outcome
Title Clinical Tolerance of Lactobacillus Reuteri (Lr) Strain DSM 17938 Based on Number of Days With Subjective Fever Reported
Hide Description [Not Specified]
Time Frame Day 0 through 6 weeks after Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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
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
Overall Number of Participants Analyzed 30 15
Overall Number of Units Analyzed
Type of Units Analyzed: Days of observation
1230 615
Measure Type: Number
Unit of Measure: days with symptom reported
15 2
Time Frame 6 months from initiation of study
Adverse Event Reporting Description AEs are scored as grade 1= mild, grade 1= moderate, grade 3 = severe, and grade 4 = life threatening based on the subject’s interpretation of their symptom severity.
 
Arm/Group Title Lactobacillus Reuteri Group Placebo Group
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 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
All-Cause Mortality
Lactobacillus Reuteri Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lactobacillus Reuteri Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Lactobacillus Reuteri Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/30 (90.00%)      13/15 (86.67%)    
Gastrointestinal disorders     
Nausea and vomiting  1  5/30 (16.67%)  8 4/15 (26.67%)  7
Diarrhea  1  9/30 (30.00%)  10 4/15 (26.67%)  4
Abdominal pain  1  8/30 (26.67%)  13 6/15 (40.00%)  10
Infections and infestations     
Fever  1  5/30 (16.67%)  6 2/15 (13.33%)  2
Injury, poisoning and procedural complications     
laceration  1  2/30 (6.67%)  2 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  8/30 (26.67%)  13 5/15 (33.33%)  8
Lumbar pain  1  15/30 (50.00%)  22 5/15 (33.33%)  9
Nervous system disorders     
Headache  1  20/30 (66.67%)  38 9/15 (60.00%)  23
Renal and urinary disorders     
dysuria  1  6/30 (20.00%)  17 3/15 (20.00%)  7
Reproductive system and breast disorders     
vaginal discharge  1  2/30 (6.67%)  2 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Rhinorrhea  1  13/30 (43.33%)  17 5/15 (33.33%)  7
cough  1  4/30 (13.33%)  6 3/15 (20.00%)  4
sore throat  1  8/30 (26.67%)  10 5/15 (33.33%)  6
Skin and subcutaneous tissue disorders     
Rash  1  4/30 (13.33%)  6 1/15 (6.67%)  1
Pruritis  1  2/30 (6.67%)  3 3/15 (20.00%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, Per protocol
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: Dr. Richard Oberhelman
Organization: Tulane University School of Public Health and Tropical Medicine
Phone: 504-988-2511
EMail: oberhel@tulane.edu
Layout table for additonal information
Responsible Party: Richard A. Oberhelman, Tulane University School of Medicine
ClinicalTrials.gov Identifier: NCT00774163     History of Changes
Other Study ID Numbers: FDA IND# 13710
1R01AT002733-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 15, 2008
First Posted: October 17, 2008
Results First Submitted: June 13, 2012
Results First Posted: July 12, 2013
Last Update Posted: December 19, 2016