About this trial
The study likely to yield improved therapeutic modalities for children with prolonged diarrhea, a sequalae often leads to persistent diarrhea, which is linked to as much as 35% of diarrhea-associated deaths in children \<5 years of age. If found effective, the therapy would led to early recovery, reduce duration of hospitalization, intercurrent hospital infection and overall expenditure related to this illness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: > 6 to 59 months
Sex: Either
Duration of diarrhea: 7 to 13 days
Children able to take oral feeds at the time of randomization
Disqualifiers
Children whose parents/care givers do not provide consent
Children presented with severe pneumonia, septic shock, convulsion or any other illness that needs ICU support during the admission.
Birth defect like complex congenital heart diseases, cleft lip and cleft palate, Down syndrome and Cerebral palsy.
Children diagnosed as having apparent or known tuberculosis or HIV or PD (≥ 14 days)/organic diarrhea.
Trial design
Parallel
Treatments tested in this trial
MS
DrugStandard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml.
MS +GB
DrugInvestigators will use the food items including green banana (Musa paradisiacal sapientum). Unripe, whole GB fruit will be cooked in boiling water and 200 gram (wet weight) of it will be used to make a total 1000 ml milk suji. The control group will receive milk suji (without any added green banana);the standard practice of study site (Dhaka Hospital, icddr,b)
Treatment groups
Trial outcomes
Primary outcomes
• Primary outcome: Clinical cure or Cessation of diarrhea
Clinical cure: \<3 liquid stools/24 hours after randomization Cessation of diarrhea: passage of soft/formed or no stool for consecutive two 8-hour periods
Sponsors and contacts
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