Clinical trial NCT02708238: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infantile Colics
Keywords: Infantile colics
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Median Daily Crying Time at the End of the Treatment
timeFrame: 28 days of treatment
Secondary outcomes:
measure: Number of Responders
timeFrame: 28 days of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Federico II University
name: Annamaria Staiano, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.