The Effect of Probiotics in Infantile Colic (CSUB0214)
Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Effect of L. Reuteri on Crying and Fussing Time in Infants With Infantile Colic
Academic, independent, non-commercial, multicenter study sponsored by the Department of Translational Medical Sciences (DISMET), University of Naples Federico II. The study evaluates whether daily oral supplementation with L reuteri reduces crying and fussing time more rapidly than an indistinguishable placebo in otherwise healthy infants with Rome IV infantile colic.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Eligible participants will meet the clinical description for having infant colic. Participants will be assessed for eligibility at the screening visit and must meet all specified inclusion and exclusion criteria. Based on screening examinations, the individual Family Pediatrician (PLS) is solely responsible for determining clinical eligibility and making the final enrollment decision, which will be documented on the Participant Screening and Enrolment Log. The Scientific Coordinator will exclusively monitor aggregate screening logs and enrollment targets across all active sites, without direct involvement in the clinical selection. Fifty infants will be randomized 1:1 to probiotic or placebo. Each participant will complete a 7-day run-in, 21 days of treatment and 7 days of safety follow-up.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Robeto Berni Canani, PhD, MD
- Telefonnummer: +390817462680
- E-post: berni@unina.it
Studieorter
-
-
-
Naples, Italien, 80100
- Rekrytering
- Family pediatricians
-
Kontakt:
- Roberto Berni Canani, MD, PhD
- Telefonnummer: +390817462680
- E-post: berni@unina.it
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age 3-12 weeks at screening;
- gestational age 37+0 to 42+0 weeks;
- birth weight appropriate or large for gestational age;
- parent/caregiver/legal guardian older than 18 years;
- exclusive or predominant breastfeeding (>50%);
- willingness to maintain feeding pattern and complete diaries and questionnaires;
- physician-confirmed Rome IV infantile colic, parental report of ≥3 hours of crying/fussing per day on ≥3 days in the prior week, and ≥3 hours in at least one 24-hour period documented in the run-in diary;
- written informed consent; mother available for scheduled visits; infant otherwise clinically healthy.
Exclusion Criteria:
- Severe gastroesophageal reflux (as defined in the protocol);
- failure to thrive;
- intrauterine growth restriction;
- hematochezia;
- significant diarrhea or fever ≥38 °C;
- congenital heart disease, immunodeficiency, asplenia, malignancy, cystic fibrosis or liver disease;
- probiotic or systemic/oral antibiotic use in the 7 days before screening or anticipated use during the study;
- use of treatments for infantile colic; including proton pump inhibitors; in the 7 days before screening or during the study.
- Infant and mother must not participate concurrently in another interventional clinical study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Probiotic
Probiotic: L. reuteri total 2 × 10⁸ CFU/day, 5 oral drops once daily for 21 days |
5 oral drops once daily for 21 days. |
|
Placebo-jämförare: Placebo
Placebo: matching oil formulation without L. reuteri, 5 oral drops once daily for 21 days. |
5 oral drops once daily for 21 days. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Daily total crying and fussing time at day 7
Tidsram: 7 days after initiation of intervention
|
Total infant crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
7 days after initiation of intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in daily total crying and fussing time from baseline to day 7
Tidsram: At Day 0 and at day 7 of intervention
|
Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
At Day 0 and at day 7 of intervention
|
|
Change in daily total crying and fussing time from baseline to every day during 21days of treatment
Tidsram: During 21 days of treatment
|
Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
During 21 days of treatment
|
|
Proportion of responder patients assessed using a parent-completed daily sleep diary (Baby's Day Diary)
Tidsram: During the first 21 days of treatment
|
Proportion of patients responders to the treatment, defined as the number of infants with ≥50% reduction in crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
During the first 21 days of treatment
|
|
Sleeping time
Tidsram: During the first 21 days of treatment
|
Total infant sleep duration, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary |
During the first 21 days of treatment
|
|
PedsQL Family Impact Module
Tidsram: During 21 days of treatment
|
Changes in PedsQL Family Impact Module range 0-100 (with higher scores reflecting better functioning) from baseline to Days 7 and 21 |
During 21 days of treatment
|
|
Maternal Edinburgh Postnatal Depression Scale score
Tidsram: During 21 days of treatment
|
Changes in Maternal Edinburgh Postnatal Depression Scale score evaluation Total score range: 0 to 30 (higher score on the Edinburgh Postnatal Depression Scale (EPDS) indicates a greater severity of symptoms) from baseline to Days 7 and 21 |
During 21 days of treatment
|
|
Number of participants experiencing adverse events and serious adverse events.
Tidsram: From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events
|
Number of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study. Events will be recorded and characterized according to type, severity, seriousness, and relationship to the study intervention. |
From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events
|
|
Body temperature
Tidsram: At day 0 and 21
|
body temperature (°C) |
At day 0 and 21
|
|
Heart rate
Tidsram: At day 0 and 21
|
heart rate (BPM) |
At day 0 and 21
|
|
Respiratory rate
Tidsram: At day 0 and 21
|
Respiratory rate/minute |
At day 0 and 21
|
|
Blood pressure
Tidsram: At day 0 and 21
|
blood pressure (mmHg) |
At day 0 and 21
|
|
Height
Tidsram: At day 0 and 21
|
Height in cm |
At day 0 and 21
|
|
Weight
Tidsram: At day 0 and 21
|
Weight in Kg |
At day 0 and 21
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 204/26
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