Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children (GB in ProD) (GB in ProD)
Randomized Double-blind Efficacy Trial of Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Objectives: The Primary objective is to determine if feeding boiled green banana (GB) added to Milk suji diet (GB-Milk Suji) compared to standard milk-based diet (Milk-suji), reduces the duration and severity of diarrhoeal illness; the Secondary objective is less frequent stool in children of 6-59 months of age with ProD.
Methods: This will be Randomized double-blind clinical trial that will be conducted in the Dhaka Hospital of icddr,b. Children of age 6-59 month with history of diarrhea for 7-13 days will be enrolled. They will be randomly assigned to either GB-Milk suji diet (n=52) or milk suji diet (n=52) for 5 days. Stool output, consistency, frequency and clinical condition will be monitored daily. The participants will be discharged home after clinical improvement/cessation of diarrhea or switch over to other diet as per algorithm and other standard care practiced in the hospital if not recovered by end of day-5.
Outcome measures/variables:
- Primary outcome: Clinical cure (<3 liquid stools/24 hours after randomization) or Cessation of diarrhea (passage of soft/formed or no stool for consecutive two 8-hour periods)
- Secondary outcomes: i) Marked improvement (≤5 liquid stools/24 hours by end of day-5); ii) Duration of diarrhea (last liquid stool after randomization) iii) Stool output; iv) Amount of IV and ORS needed.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Dhaka Division
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Dhaka, Dhaka Division, Bangladesh, 1212
- Dhaka Hospital, icddr,b
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Contact:
- Shamima Sultana, MBBS, MPH
- Telefoonnummer: +8801715151404
- E-mail: shamima@icddrb.org
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
- Non-Severe Acute Malnutrition (SAM).
- Not participating in another clinical study, the preceding 4 weeks
- Parent willing to participate to the present study and providing informed written consent
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Milk suji
milk suji |
Standard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml. |
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Experimenteel: Arm MS +GB
milk + GB |
Investigators 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) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
• Primary outcome: Clinical cure or Cessation of diarrhea
Tijdsspanne: Within 5 days from randomization
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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 |
Within 5 days from randomization
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- PR-26-062
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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