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

NCT02708238 | Completed Phase 4 Results

• 1 other identifier: 04032016
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infantile Colics

Keywords

Infantile colics

Outcome Measures

Primary Outcomes (1)

• Median Daily Crying Time at the End of the Treatment

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

  28 days of treatment

Secondary Outcomes (1)

• Number of Responders

  28 days of treatment

Study Arms (3)

Group A

EXPERIMENTAL

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)

Group B

ACTIVE COMPARATOR

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)

Group C

ACTIVE COMPARATOR

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

Interventions

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

Group A

Lactobacillus reuteri DSM 17938 (108 CFU) DIETARY_SUPPLEMENT

Group B

Simethicone DRUG

Group C

Eligibility Criteria

• Age: 14 Days - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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);
• minute Apgar score ≥7; and 6) birth weight ≥2500 g

You may not qualify if:

• a major medical problem or acute illness;
• family history of atopy;
• history of antibiotic treatment before or during the study;
• history of probiotic supplementation.

Sponsors & Collaborators

• Federico II University: lead

Related Publications (1)

• 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.

  PMID: 28665038 DERIVED

MeSH Terms

Interventions

Simethicone

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

The absence of a placebo group and the open label design represent the main limitations of this study

Results Point of Contact

• Title: Annamaria Staiano
• Organization: Department of Translational Medical Sciences, Section of Pediatrics, University of Naples "Federico II"

staiano@unina.it

00390817462679

Study Officials

• Annamaria Staiano, Prof.

  Federico II University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 15, 2016
• Study Start: April 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 29, 2016
• Results First Posted: July 29, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share