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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
- Central Park Teaching Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 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. |
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Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Clinical efficacy of probiotic treatment
Prazo: 3 days
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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
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CPMC/IRB-No/1503
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