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

Primary Purpose

Infantile Colics

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)
Lactobacillus reuteri DSM 17938 (108 CFU)
Simethicone
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colics focused on measuring Infantile colics

Eligibility Criteria

14 Days - 4 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Group A

    Group B

    Group C

    Arm 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

    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

    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

    Outcomes

    Primary Outcome Measures

    Median Daily Crying Time at the End of the Treatment
    Median daily crying at the end of treatment (day 28).

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 4, 2016
    Last Updated
    June 20, 2016
    Sponsor
    Federico II University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02708238
    Brief Title
    Efficacy of Matricariae Chamomilla L., Melissa Officinalis L. and Tyndallized Lactobacillus Acidophilus (H122) for Infantile Colics
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federico II University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infantile Colics
    Keywords
    Infantile colics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Group B
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Group C
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus reuteri DSM 17938 (108 CFU)
    Intervention Type
    Drug
    Intervention Name(s)
    Simethicone
    Primary Outcome Measure Information:
    Title
    Median Daily Crying Time at the End of the Treatment
    Description
    Median daily crying at the end of treatment (day 28).
    Time Frame
    28 days of treatment
    Secondary Outcome Measure Information:
    Title
    Number of Responders
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Days
    Maximum Age & Unit of Time
    4 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of IC according to Rome III criteria (2); age ≥2 weeks to 4 months; breast-fed or fomula-fed infants; term delivery (≥37 weeks gestation at birth); 5-minute Apgar score ≥7; and 6) birth weight ≥2500 g Exclusion Criteria: a major medical problem or acute illness; family history of atopy; history of antibiotic treatment before or during the study; history of probiotic supplementation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Annamaria Staiano, Prof.
    Organizational Affiliation
    Federico II University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Publication
    Citations:
    PubMed Identifier
    28665038
    Citation
    Martinelli M, Ummarino D, Giugliano FP, Sciorio E, Tortora C, Bruzzese D, De Giovanni D, Rutigliano I, Valenti S, Romano C, Campanozzi A, Miele E, Staiano A. Efficacy of a standardized extract of Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (HA122) in infantile colic: An open randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12). doi: 10.1111/nmo.13145. Epub 2017 Jun 30.
    Results Reference
    derived

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

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