Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Comparison of Effectiveness of Bacillus Clausii and Multistrain Probiotics (Lactobacillus Acidophilus, Lactobacillus Bulgaricus, Bifidobacterium, Streptococcus Thermophilus) in the Management of Children With Acute Watery Diarrhea: A Randomised Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Acute watery diarrhea is a major cause of morbidity among children worldwide, particularly in developing countries. Although oral rehydration solution (ORS) and zinc supplementation remain the cornerstone of treatment, probiotics are increasingly used as adjunctive therapy to reduce the duration and severity of illness.
Bacillus clausii and multistrain probiotic preparations have both demonstrated beneficial effects in children with acute diarrhea. However, evidence comparing their relative effectiveness is limited. This study aims to compare the effectiveness of Bacillus clausii (Enterogermina) and a multistrain probiotic preparation (Ecotec) containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus in the management of acute watery diarrhea in children.
This study is a randomized, open-label, parallel-group controlled trial conducted in the Department of Pediatric Medicine at The Children's Hospital and Institute of Child Health, Lahore. A total of 138 children aged 1-5 years with acute watery diarrhea will be enrolled and randomized in a 1:1 ratio into two treatment groups.
Participants in Group A will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to ORS and zinc supplementation. Participants in Group B will receive the multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to ORS and zinc supplementation.
The primary outcome is duration of diarrhea. Secondary outcomes include stool frequency and stool consistency during the treatment period. The findings of this study may help identify the more effective probiotic strategy for the management of acute watery diarrhea in children and contribute to evidence-based pediatric practice.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mamoona feroz
- Numéro de téléphone: +923315616443
- E-mail: mamoona.feroz@yahoo.com
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Children Hospital and Institute of Child Health, Lahore
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Contact:
- Mamoona feroz
- Numéro de téléphone: +923315616443
- E-mail: mamoona.feroz@yahoo.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patient with Acute watery diarrhea aged 1 year to 5 years.
- Both genders will be included.
- Patients whose guardians/ parents will give informed consent will participate in the study.
- Patients having mild to moderate dehydration will be included in study.
- Patients having mild to moderate malnutrition will be included in study.
Exclusion Criteria:
- Children having history of chronic diarrhea.
- Children having history of blood in stools.
- Children having cholera.
- Children with evidence of concurrent systemic infections other than acute diarrhea (e.g. respiratory tract infections, urinary tract infections, measles, meningitis etc).
- Children with known immunodeficiency disorders or undergoing immunosuppressive treatments (e.g., chemotherapy, corticosteroids).
- Children who have received antibiotics or zinc within the past 72 hours prior to enrollment, as this may interfere with gut flora and probiotic efficacy.
- Children who have received probiotics as a treatment for the current episode of diarrhea prior to study enrollment.
- Children with known allergies or hypersensitivity to probiotic components used in the study.
- Children who needed I/V antibiotics or I/V rehydration after enrollment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Bacillus clausii Group
Participants will receive Bacillus clausii (Enterogermina) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.
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Bacillus clausii oral suspension containing 2 billion spores administered once daily for 5 days.
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Comparateur actif: Multistrain Probiotic Group
Participants will receive a multistrain probiotic preparation (Ecotec) once daily for 5 days in addition to standard treatment with oral rehydration solution (ORS) and zinc supplementation.
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Multistrain probiotic preparation containing Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium species, and Streptococcus thermophilus administered once daily for 5 days.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Duration of Diarrhea
Délai: Up to 5 days after initiation of treatment
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The duration of acute diarrhea is determined by the timeframe (measured in days) spanning from the initial occurrence of abnormal (loose or liquid) stools to the subsequent return of normal stool consistency.
This assessment will consider both the frequency of daily stools and their consistency.
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Up to 5 days after initiation of treatment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Daily Stool Frequency
Délai: Daily for 5 days after initiation of treatment
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Number of stools passed per day during the treatment period.
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Daily for 5 days after initiation of treatment
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Stool Consistency
Délai: Daily for 5 days after initiation of treatment
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Change in stool consistency assessed daily during the treatment period.
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Daily for 5 days after initiation of treatment
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UCHS-MDPEDS-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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