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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Dhaka Division
-
Dhaka, Dhaka Division, Bangladesh, 1212
- Dhaka Hospital, icddr,b
-
Ta kontakt med:
- Shamima Sultana, MBBS, MPH
- Telefonnummer: +8801715151404
- E-post: shamima@icddrb.org
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Eksperimentell: 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) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
• Primary outcome: Clinical cure or Cessation of diarrhea
Tidsramme: Within 5 days from randomization
|
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
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- PR-26-062
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .