Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06458881 |
| Other study ID # |
196/2023 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2023 |
| Est. completion date |
February 28, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic
according to Rome IV criteria. We administered to all the enrolled infants a mixture of
Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean
infant crying duration at 28th day. The secondary outcome was the improvement in the quality
of sleep and infants' and parents' quality of life
Description:
This pilot study is a prospective study coordinated by the Department of Translational
Medicine, Section of Pediatrics, University of Naples "Federico II", whereas infants were
recruited by 8 general pediatricians belonging to the Pediatrics Investigator Committee of
Campania Region, Italy. Inclusion criteria were: full term infants (>_37 weeks gestation at
birth; 5-min Apgar score >_7; Birth weight >_2500 g), aged <12 months, diagnosed with IC
according to Rome IV criteria [1], breast- and formulafed infants. The parents of the infants
participating in the study were supplied with the mixture of Tyndallized B. Coagulans and
Simethicone. The Institutional Review Board of Campania 3 approved the research protocol. All
parents gave written informed consent. Enrolled infants were treated for 28 days with a
mixture of Tyndallized B. Coagulans and Simethicone: 20 drops, four times a day. At
enrolment, clinical and dietary history, obstetrical data and anthropometry were recorded.
The subjects were classified as having IC based on their parents' responses to the validated
questionnaires regarding IC according to Rome IV criteria. The parents were also asked to
fill in the following questionnaires: 1) Baby's Day Diary on daily crying and infant sleep
duration [21]; 2) a scale (visual analogue scale, VAS, 0e10) for parents' quality of life, a
questionnaire on infant's quality of life; 3) a form for stool frequency and consistency; 4)
a scale for parental perception of colic severity (VAS 0e10) and 5) a scale for parental
perception of sleep quality (VAS 0 e10). Infants were evaluated by a physician for follow-up
visits at week 4. During the visits, physical examination was performed and information
regarding drugs administration, number and site of infections and eventual adverse medical
events were recorded. Moreover, parents had to fill: 3) the questionnaire on infant's quality
of life; 4) a review of stool frequency and consistency; 5) the parental perception of colic
severity (VAS 0e10) and 6) the parental perception of sleep quality (VAS 0e10). All the
authors had access to the study data. Compliance was assessed by evaluating the diary
provided by the parents.
Outcomes The primary endpoint was the infant crying duration at 28 days. Treatment success
was defined as at least 50% reduction in crying time from baseline to day 28
postintervention. Secondary endpoints included: infant sleep duration at 28 days
post-intervention, mean scores on a standardized measure of parents' and infants' quality of
life, changes in stool consistency, number of episodes of infant colic per day, parental
perception of colic severity (VAS 0-10), parental perception of quality of life (VAS0-10).
