Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
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|ClinicalTrials.gov Identifier: NCT02708238|
Recruitment Status : Completed
First Posted : March 15, 2016
Results First Posted : July 29, 2016
Last Update Posted : July 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Infantile Colics||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||Phase 4|
This will be a prospective, multicentre, open label, randomized, controlled trial. All consecutive infants diagnosed with IC, according to Rome III criteria, will be prospectively enrolled in a 12 months period by 3 different Pediatric Gastroenterology units: Department of Translational Medical Science, Section of Pediatrics, University of Naples "Federico II"; Institute of Pediatrics of the University of Foggia; Endoscopy and Gastroenterology Unit, Department of Pediatrics, University of Messina.
After the enrollment, all children will be randomly assigned to receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122) (Group A), L reuteri DSM 17938 (108 CFU) (Group B) or Simethicone (Group C). Treatment will be given to subjects for 28 days. The study's primary outcome is defined as a reduction in the duration of average crying times, from baseline (day 0) to end of treatment (day 28). The secondary outcome measure is the number of participants who respond to treatment on days 28. Infants who experience a decrease in the daily average crying time of 50% from baseline will be considered as responders to the treatment. Parents will be instructed to complete a structured 28-day maternal diary, modified from Barr et al. in order to record the frequency of colic episodes and the daily crying and fussing time (in minutes), feeding schedule, stool frequency and characteristics, and any adverse events experienced (14). Follow-up visits will be conducted on study days 7, 14, 21 and 28 by the same study investigator. At that visit, diaries and unused study products will be returned.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Standardized Extract of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) Compared With Lactobacillus Reuteri (DSM 17938) and With Simethicone for the Treatment of Infantile Colic|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
Experimental: 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
Dietary Supplement: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)
Active Comparator: 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
Dietary Supplement: Lactobacillus reuteri DSM 17938 (108 CFU)
Active Comparator: Group C
All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 15 drops two times per day of a commercially available solution
- Median Daily Crying Time at the End of the Treatment [ Time Frame: 28 days of treatment ]Median daily crying at the end of treatment (day 28).
- Number of Responders [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02708238
|Principal Investigator:||Annamaria Staiano, Prof.||Federico II University|