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

NCT ID: NCT02708238

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-07-31

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.

Conditions

Infantile Colics

Keywords

Infantile colics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: ACTIVE_COMPARATOR

Lactobacillus reuteri DSM 17938 (108 CFU)

Intervention Type: DIETARY_SUPPLEMENT

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

Group Type: ACTIVE_COMPARATOR

Simethicone

Intervention Type: DRUG

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 (108 CFU)

Intervention Type: DIETARY_SUPPLEMENT

Simethicone

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Erasmo Miele

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annamaria Staiano, Prof.

Role: PRINCIPAL_INVESTIGATOR

Federico II University

References

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.

Reference Type: DERIVED

PMID: 28665038 (View on PubMed)

Other Identifiers

04032016

Identifier Type: -

Identifier Source: org_study_id