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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Robeto Berni Canani, PhD, MD
- Telefonní číslo: +390817462680
- E-mail: berni@unina.it
Studijní místa
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-
-
Naples, Itálie, 80100
- Nábor
- Family pediatricians
-
Kontakt:
- Roberto Berni Canani, MD, PhD
- Telefonní číslo: +390817462680
- E-mail: berni@unina.it
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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. |
|
Komparátor placeba: Placebo
Placebo: matching oil formulation without L. reuteri, 5 oral drops once daily for 21 days. |
5 oral drops once daily for 21 days. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Daily total crying and fussing time at day 7
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in daily total crying and fussing time from baseline to day 7
Časové okno: 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
Časové okno: 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)
Časové okno: 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
|
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Sleeping time
Časové okno: 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
Časové okno: 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
|
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Maternal Edinburgh Postnatal Depression Scale score
Časové okno: 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
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Number of participants experiencing adverse events and serious adverse events.
Časové okno: 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
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Body temperature
Časové okno: At day 0 and 21
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body temperature (°C) |
At day 0 and 21
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Heart rate
Časové okno: At day 0 and 21
|
heart rate (BPM) |
At day 0 and 21
|
|
Respiratory rate
Časové okno: At day 0 and 21
|
Respiratory rate/minute |
At day 0 and 21
|
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Blood pressure
Časové okno: At day 0 and 21
|
blood pressure (mmHg) |
At day 0 and 21
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Height
Časové okno: At day 0 and 21
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Height in cm |
At day 0 and 21
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Weight
Časové okno: At day 0 and 21
|
Weight in Kg |
At day 0 and 21
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 204/26
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