Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
Comparison of the Clinical Efficacy of Bacteria-Based Probiotics to Fungi-Based Probiotics in Acute Watery Diarrhea in Pediatric Outpatient Department
THIS STUDY WILL BE CONDUCTED ON OPD PATIENTS IN CENTRAL PARK TEACHING HOSPITAL LAHORE TO SEE THE EFFECT OF PROBIOTICS ON DIARRHEA ALL PATIENTS INCLUDED WILL HAVE ACUTE WATERY DIARRHEA AND THE OUTCOME WILL BE CHECKED ON THE THIRD DAY OF ADMISSION
調査の概要
詳細な説明
This study is planning to compare the clinical efficacy of bacterial ( Bacillus clausii) versus fungal (Sacchromyces boulardii) probiotic in acute watery diarrhea. A clear consensus has not been reached regarding the use of appropriate probiotic. Some pediatricians are of the opinion that bacterial probiotic are suprerior to fungal probiotics along with rehydration for improvement of diarrhea. However, others experience is that fungal probiotics are better along with rehydration for the improvement of diarrhea. A high-quality evidence basis must be established that guides the pediatrician regarding the choice of probiotic.The results of this study will help guide pediatricians to the better probiotic for the clinical improvement of acute diarrhea in our setup.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54000
- Central Park Teaching Hospital
-
-
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:
- Children aged 0 to 59 months
- Acute Watery Diarrhea
- The child's parents or caregiver understands, agrees to participate, and complies with the study protoco
Exclusion Criteria:
- Patients with bloody diarrhea, severe dehydration, severe electrolyte imbalance, immunocompromised children, or malabsorption disorders and systemic illnesses (sepsis, pneumonia, urinary infections)
- Those who have already used antibiotics or probiotics during this illness
- Known hypersensitivity to probiotics
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：なし（オープンラベル）
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：BACILLUS CLAUSII
Participants will receive bacterial-based probiotic Bacillus clausii (2 billion spores), administered orally twice daily, in addition to standard diarrheal treatment. Participants will be followed for 3 days to assess clinical efficacy based on stool frequency and consistency. |
Bacillus clausii, a bacterial-based probiotic, will be administered orally at a dose of 2 billion spores twice daily for 3 days, in addition to standard diarrheal treatment. Clinical efficacy will be assessed on the 3rd day based on stool frequency and consistency. |
|
アクティブコンパレータ：SACCHROMYCES BOULARDII
Participants will receive fungal-based probiotic Saccharomyces boulardii 250 mg, administered orally twice daily, in addition to standard diarrheal treatment. Participants will be followed for 3 days to assess clinical efficacy based on stool frequency and consistency. |
Saccharomyces boulardii, a fungal-based probiotic, will be administered orally at a dose of 250 mg twice daily for 3 days, in addition to standard diarrheal treatment. Clinical efficacy will be assessed on the 3rd day based on stool frequency and consistency. |
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 |
|---|---|---|
|
Clinical efficacy of probiotic treatment
時間枠：3 days
|
Clinical efficacy will be assessed on the 3rd day. A positive outcome will be defined as ≤3 episodes of stool with Bristol stool grade 5 or less. The clinical efficacy of Bacillus clausii will be compared with Saccharomyces boulardii in children with acute watery diarrhea. |
3 days
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Awais M, Alam S, Wali N, Mehmood R, Nasir U, Waheed A. Comparison of the Clinical Efficacy of Bacteria-Based Probiotics to Fungi-Based Probiotics. 7.
- Sharif A, Ardakani AT, Kashani HH, Rabiee F, Sharif MR. Comparison Efficacy of Bacterial and Fungal Probiotics on Acute Pediatric Diarrhea A Randomized Clinical Trial [Internet]. 2019 [cited 2024 Sept 3]. Available from: https://www.researchsquare.com/article/rs-2183/v1
- Erdogan O, Tanyeri B, Torun E, Gonullu E, Arslan H, Erenberk U, Oktem F. The comparition of the efficacy of two different probiotics in rotavirus gastroenteritis in children. J Trop Med. 2012;2012:787240. doi: 10.1155/2012/787240. Epub 2012 Jun 19.
- Khan MH, Khan MS. Comparison of Multispecies Probiotic and Saccahomyces Boulardii in Children with Acute Watery Diarrhea in Terms of Mean Duration of Diarrhea.
- Sharma AK, Puri N, Mathur M, Mathur A. A randomized controll trial to compare the efficacy of saccharomyces boulardii, bacillus clausii, and lactobacillus rhamnosus GG preparation in the treatment of acute diarrhea in children. Asian J Pharm Clin Res. 2022 Mar 14;63-7.
- Syed M, Gondi S, D V, P U. Study on efficacy of probiotic use in pediatric acute diarrhea: A prospective open-labeled study. Natl J Physiol Pharm Pharmacol. 2023;14(5):1
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
追加の関連 MeSH 用語
その他の研究ID番号
- CPMC/IRB-No/1503
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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