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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
Sponsor:
Information provided by (Responsible Party):
Erasmo Miele, Federico II University

Study Description
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Brief Summary:
A multicenter prospective, randomized comparative study will be conducted in infants with colic, according to Rome III criteria. Enrolled infants will be assigned at random to receive Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122), L reuteri DSM 17938 (108 CFU) or simethicone. Treatment will be given to subjects for 28 days and they will be followed for 4 weeks. Treatment success will be assessed at the end of study period. Daily crying and fussing times will be recorded in a structured diary, and maternal questionnaires will be completed to monitor changes in infant colic symptoms and adverse events.

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Simethicone


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   14 Days to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. diagnosis of IC according to Rome III criteria (2);
  2. age ≥2 weeks to 4 months;
  3. breast-fed or fomula-fed infants;
  4. term delivery (≥37 weeks gestation at birth);
  5. 5-minute Apgar score ≥7; and 6) birth weight ≥2500 g

Exclusion Criteria:

  1. a major medical problem or acute illness;
  2. family history of atopy;
  3. history of antibiotic treatment before or during the study;
  4. history of probiotic supplementation.
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Annamaria Staiano, Prof. Federico II University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Erasmo Miele, Researcher, Federico II University
ClinicalTrials.gov Identifier: NCT02708238    
Other Study ID Numbers: 04032016
First Posted: March 15, 2016    Key Record Dates
Results First Posted: July 29, 2016
Last Update Posted: July 29, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication
Keywords provided by Erasmo Miele, Federico II University:
Infantile colics
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases
Simethicone
Antifoaming Agents
 Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents