Infantile Colics
Conditions
Keywords
Infantile colics
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.
Interventions
DIETARY_SUPPLEMENTStandardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)
DIETARY_SUPPLEMENTLactobacillus reuteri DSM 17938 (108 CFU)
DRUGSimethicone
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Days to 4 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Daily Crying Time at the End of the Treatment | 28 days of treatment | Median daily crying at the end of treatment (day 28). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Responders | 28 days of treatment | Number of responders defined as the number of patients who experienced a decrease in the daily average crying time of 50% from baseline |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122) | 60 |
| 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
Lactobacillus reuteri DSM 17938 (108 CFU) | 59 |
| Group C All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution
Simethicone | 57 |
| Total | 176 |
Baseline characteristics
| Characteristic | Group B | Group C | Group A | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 59 Participants | 57 Participants | 60 Participants | 176 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 35 Days | 30 Days | 38 Days | 35 Days |
| Region of Enrollment Italy | 59 participants | 57 participants | 60 participants | 176 participants |
| Sex: Female, Male Female | 21 Participants | 39 Participants | 31 Participants | 91 Participants |
| Sex: Female, Male Male | 38 Participants | 18 Participants | 29 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 59 | 0 / 57 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 | 0 / 57 |
Outcome results
Primary
Median Daily Crying Time at the End of the Treatment
Median daily crying at the end of treatment (day 28).
Time frame: 28 days of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group A | Median Daily Crying Time at the End of the Treatment | 50 minutes |
| Group B | Median Daily Crying Time at the End of the Treatment | 55 minutes |
| Group C | Median Daily Crying Time at the End of the Treatment | 80 minutes |
Secondary
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
Time frame: 28 days of treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A | Number of Responders | 57 number of responders |
| Group B | Number of Responders | 47 number of responders |
| Group C | Number of Responders | 38 number of responders |