Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea
Effectiveness of Saccharomyces Boulardii in the Prevention of Antibiotic-Associated Diarrhea Among Children Receiving Co-amoxiclav for Upper Respiratory Tract Infection: A Randomized Control Trial
調査の概要
詳細な説明
Acute upper respiratory tract infections (URTI) frequently lead to broad-spectrum antibiotic prescriptions such as co-amoxiclav, which can disrupt the gut microbiota and cause antibiotic-associated diarrhea (AAD).
This single-blind randomized controlled trial will be conducted at the Pediatric Medicine Outpatient Department, University of Child Health Sciences, The Children's Hospital, Lahore. A total of 88 children aged 6 months to 5 years presenting with URTI and prescribed co-amoxiclav will be enrolled after obtaining written informed consent from their parents or legal guardians.
Participants will be randomized into two equal groups (n = 44 each):
Group A (Control): Standard dose of oral co-amoxiclav (30 mg/kg/day) for 5 days.
Group B (Intervention): Standard dose of oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.
Clinical response, stool frequency, and stool consistency (graded using the WHO scale) will be assessed telephonically and during clinical follow-up at Day 5 (completion of antibiotic regimen) and at Day 14. Any child developing severe dehydration or high-grade loose stools will be managed in accordance with institutional safety protocols.
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：Gul Jabeen, MBBS
- 電話番号：+923330937322
- メール：aabigul96@gmail.com
研究場所
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Punjab Province
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Lahore、Punjab Province、パキスタン
- University of Child Health sciences, Children's hospital,Lahore
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コンタクト：
- Gul Jabeen, MBBS
- 電話番号：+923330937322
- メール：aabigul96@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Children aged 6 months to 5 years presenting with upper respiratory tract infection (URTI)
- Prescribed standard oral co-amoxiclav therapy
- Both male and female patients
- Written informed consent provided by parents or legal guardians
Exclusion Criteria:
- Presence of diarrhea at the time of study enrollment
- Prior use of probiotics during the current course of illness
- Receipt of any antibiotic other than co-amoxiclav within the 72 hours preceding enrollment
- Concomitant use of other medications
- Known allergy to co-amoxiclav or the probiotic Saccharomyces boulardii
- Confirmed immunodeficiency disorder or current receipt of immunosuppressive therapy
- History of chronic diarrhea
- Presence of 3rd degree (severe) malnutrition
- Presence of systemic symptoms or infections other than URTI (e.g., lower respiratory tract infection, jaundice)
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Group A: Control Group
Participants receive standard oral co-amoxiclav (30 mg/kg/day) for 5 days.
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30 mg/kg/day orally for 5 days.
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実験的：Group B:Intervention Group
Participants receive standard oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.
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30 mg/kg/day orally for 5 days.
Administered orally alongside standard co-amoxiclav for 5 days.
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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 |
|---|---|---|
|
Incidence of Antibiotic-Associated Diarrhea (AAD)
時間枠：From initiation of treatment through Day 14
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Proportion of participants who develop antibiotic-associated diarrhea, defined as 3 or more unformed/loose stools per day or a single episode of watery stool starting at least 2 hours post-initiation of co-amoxiclav therapy.
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From initiation of treatment through Day 14
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stool Frequency
時間枠：Assessed at Day 1, Day 5, and Day 14.
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Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, >4 times per day).
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Assessed at Day 1, Day 5, and Day 14.
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Stool Consistency Grade
時間枠：Assessed at Day 1, Day 5, and Day 14
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Stool consistency graded according to the WHO grading scale: Grade 1 (Normal formed), Grade 2 (Semi-formed), Grade 3 (Liquid stools taking shape of container), Grade 4 (Watery stools with flakes, opaque), Grade 5 (Watery stools with few flakes, translucent).
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Assessed at Day 1, Day 5, and Day 14
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Duration of Diarrhea
時間枠：Up to Day 14 post-initiation of therapy
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Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea.
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Up to Day 14 post-initiation of therapy
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- UCHS-MD-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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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