Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Probiotic combination: Multi-strain probiotic of Saccharomyces boulardii + Lactobacillus rhamnosus GG
Oral Route: 1 Sachet two times a day for five days
Control Intervention1: Probiot
Sponsors
CTQuest LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 02 to 12 years of age treated on OPD basis for acute diarrhea (mild, moderate dehydration) 2. 3 or more liquid or watery stool in the last 24 hours 3. Parents giving informed consent for participation. Children between 07-12 years willing to assent for the study. 4. Parent and child is able to attend all scheduled visits and to comply with the study procedures. 5. Subjectâ??s parent/legal guardian has access to a telephone.
Exclusion criteria
Exclusion criteria: 1. History of diarrhea lasting more than 48 hrs at time of consenting 2. History of blood in stools 3. Severe dehydration ( >10%, patient needs IV fluid) 4. Chronic diarrhea 5. Known hypersensitivity to any of the study probiotic 6. Severely malnourished (grade III and IV according to IAP classification- see Table 4 below 7. Clinical signs of a coexisting severe acute systemic illness (Pneumonia, sepsis, UTI, other co-morbidities) 8. Diagnosis of immune deficiency (AIDS, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc.) 9. Administration of antibiotics, probiotics or antidiarrheal 7 days before study 10. Participation in another clinical study within 30 days before the beginning or anytime during the duration of the current clinical study. 11. Subjectâ??s parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. 12. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study. Parents or guardians identified as employees of the Investigator or study center as well as family members (i.e. immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of combination of Saccharomyces boulardii + Lactobacillus rhamnosus GG in management of acute diarrhea in study population.Timepoint: Day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of combination of Lactobacillus GG and Sacharomyces Boulardii in children with acute diarrheaTimepoint: Five days | — |
Countries
India
Contacts
Public ContactDr VKGoyal
Panchsheel Hospital
Outcome results
None listed