We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics

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: NCT02708238
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : July 29, 2016
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
Erasmo Miele, Federico II University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infantile Colics
Interventions Dietary Supplement: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)
Dietary Supplement: Lactobacillus reuteri DSM 17938 (108 CFU)
Drug: Simethicone
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution

Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension

Lactobacillus reuteri DSM 17938 (108 CFU)

All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution

Simethicone

Period Title: Overall Study
Started 60 60 60
Completed 60 59 57
Not Completed 0 1 3
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group Description

All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution

Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension

Lactobacillus reuteri DSM 17938 (108 CFU)

All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution

Simethicone

Total of all reporting groups
Overall Number of Baseline Participants 60 59 57 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 57 participants 176 participants
<=18 years
60
 100.0%
59
 100.0%
57
 100.0%
176
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 60 participants 59 participants 57 participants 176 participants
38
(14 to 86)
35
(14 to 85)
30
(14 to 62)
35
(14 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 59 participants 57 participants 176 participants
Female
31
  51.7%
21
  35.6%
39
  68.4%
91
  51.7%
Male
29
  48.3%
38
  64.4%
18
  31.6%
85
  48.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 60 participants 59 participants 57 participants 176 participants
60 59 57 176
1.Primary Outcome
Title Median Daily Crying Time at the End of the Treatment
Hide Description Median daily crying at the end of treatment (day 28).
Time Frame 28 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution

Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension

Lactobacillus reuteri DSM 17938 (108 CFU)

All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution

Simethicone

Overall Number of Participants Analyzed 60 59 57
Median (Full Range)
Unit of Measure: minutes
50
(30 to 180)
55
(30 to 180)
80
(30 to 270)
2.Secondary Outcome
Title Number of Responders
Hide Description Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline
Time Frame 28 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution

Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension

Lactobacillus reuteri DSM 17938 (108 CFU)

All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution

Simethicone

Overall Number of Participants Analyzed 60 59 57
Measure Type: Number
Unit of Measure: number of responders
57 47 38
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution

Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension

Lactobacillus reuteri DSM 17938 (108 CFU)

All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution

Simethicone

All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/59 (0.00%)   0/57 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/59 (0.00%)   0/57 (0.00%) 
The absence of a placebo group and the open label design represent the main limitations of this study
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: Annamaria Staiano
Organization: Department of Translational Medical Sciences, Section of Pediatrics, University of Naples "Federico II"
Phone: 00390817462679
EMail: staiano@unina.it
Layout table for additonal information
Responsible Party: Erasmo Miele, Federico II University
ClinicalTrials.gov Identifier: NCT02708238    
Other Study ID Numbers: 04032016
First Submitted: March 4, 2016
First Posted: March 15, 2016
Results First Submitted: April 15, 2016
Results First Posted: July 29, 2016
Last Update Posted: July 29, 2016