Trial Outcomes & Findings for Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics (NCT NCT02708238)

Results Overview

Median daily crying at the end of treatment (day 28).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

180 participants

Primary outcome timeframe

28 days of treatment

Results posted on

2016-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Group A 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)	Group B 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)	Group C 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 Study STARTED	60	60	60
Overall Study COMPLETED	60	59	57
Overall Study NOT COMPLETED	0	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=60 Participants 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)	Group B n=59 Participants 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)	Group C n=57 Participants 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 n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	60 Participants n=5 Participants	59 Participants n=7 Participants	57 Participants n=5 Participants	176 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	38 Days n=5 Participants	35 Days n=7 Participants	30 Days n=5 Participants	35 Days n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants	91 Participants n=4 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	38 Participants n=7 Participants	18 Participants n=5 Participants	85 Participants n=4 Participants
Region of Enrollment Italy	60 participants n=5 Participants	59 participants n=7 Participants	57 participants n=5 Participants	176 participants n=4 Participants

PRIMARY outcome

Timeframe: 28 days of treatment

Median daily crying at the end of treatment (day 28).

Outcome measures

Outcome measures
Measure	Group A n=60 Participants 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)	Group B n=59 Participants 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)	Group C n=57 Participants 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
Median Daily Crying Time at the End of the Treatment	50 minutes Interval 30.0 to 180.0	55 minutes Interval 30.0 to 180.0	80 minutes Interval 30.0 to 270.0

SECONDARY outcome

Timeframe: 28 days of treatment

Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline

Outcome measures

Outcome measures
Measure	Group A n=60 Participants 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)	Group B n=59 Participants 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)	Group C n=57 Participants 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
Number of Responders	57 number of responders	47 number of responders	38 number of responders

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Annamaria Staiano

Department of Translational Medical Sciences, Section of Pediatrics, University of Naples "Federico II"

Phone: 00390817462679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place