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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Robeto Berni Canani, PhD, MD
- 電話番号：+390817462680
- メール：berni@unina.it
研究場所
-
-
-
Naples、イタリア、80100
- 募集
- Family pediatricians
-
コンタクト：
- Roberto Berni Canani, MD, PhD
- 電話番号：+390817462680
- メール：berni@unina.it
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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. |
|
プラセボコンパレーター：Placebo
Placebo: matching oil formulation without L. reuteri, 5 oral drops once daily for 21 days. |
5 oral drops once daily for 21 days. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Daily total crying and fussing time at day 7
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in daily total crying and fussing time from baseline to day 7
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：At day 0 and 21
|
body temperature (°C) |
At day 0 and 21
|
|
Heart rate
時間枠：At day 0 and 21
|
heart rate (BPM) |
At day 0 and 21
|
|
Respiratory rate
時間枠：At day 0 and 21
|
Respiratory rate/minute |
At day 0 and 21
|
|
Blood pressure
時間枠：At day 0 and 21
|
blood pressure (mmHg) |
At day 0 and 21
|
|
Height
時間枠：At day 0 and 21
|
Height in cm |
At day 0 and 21
|
|
Weight
時間枠：At day 0 and 21
|
Weight in Kg |
At day 0 and 21
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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