Green Banana (GB) Mixed Diet in the Management of Persistent Diarrhea (PD)

Summary

Diarrhea is the 2nd leading cause of death in under-five children. When diarrhea continued for 14 days or more it is known as Persistent Diarrhea (PD). In low and middle income countries (LMIC), 3%-23% of acute diarrheal episodes turn to PD. PD causes 32-62% of all diarrheal deaths in LMIC, and \>25% in Bangladesh in contrast to 0.8% is caused by acute diarrhea. The prevalence of PD varied from 6.3 to 16.4 %. However, no larger prospective study was conducted to evaluate the efficacy of green banana in the management of PD among children older than 6 months.An open-labeled randomized controlled clinical trial is designed to assess the efficacy of green banana mixed full strength rice suji, and full strength rice suji alone compared to 3/4th strength rice suji in the management of persistent diarrhea (PD) in children aged \> 6 months to 36 months in the Dhaka Hospital of icddr,b.

Conditions

• Persistent Diarrhea

Interventions

OTHER

GB mixed full strength rice suji

On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn't resolve, the child will be enrolled in the study and after randomization will get the Green banana mixed full strength rice suji The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.

OTHER

Full strength rice suji Alone

On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn't resolve, the child will be enrolled in the study and after randomization will get full strength rice suji alone. The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.

OTHER

3/4th strength rice suji

On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn't resolve, the child will be enrolled in the study and after randomization will get 3/4th strength rice suji. The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  lead OTHER

Principal Investigators

• Monira Sarmin, MBBS · Medical officer, ICU

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-07

Primary Completion

2021-10-30

Completion

2021-10-30

Countries

• Bangladesh

Study Locations