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

Infantile Colics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708238
• Other study ID #: 04032016
• Status: Completed
• Phase: Phase 4
• First received: March 4, 2016
• Last updated: March 14, 2016
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infantile Colics

Intervention

Dietary Supplement:
• Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

• Lactobacillus reuteri DSM 17938 (108 CFU)

Drug:
• Simethicone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in the duration of average crying times	Reduction in the duration of average crying times, from baseline (day 0) to end of treatment (day 28).	28 days of treatment	No
Secondary	Number of responders	Number of responders defined as patients who experienced a decrease in the daily average crying time of 50% from baseline	28 days of treatment	No