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

NCT03366740 | Unknown

• 1 other identifier: PR-17075
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Persistent diarrhea; > 6 to 36 months aged children; green banana; rice suji; milk suji; comminuted chicken

Outcome Measures

Primary Outcomes (1)

• By day 5, percentage of children recovered from diarrhea by the study diets

  Recovery from diarrhea is desired in PD.so, study outcome will be measured by calculating the percentage of children recovered from diarrhea by the study diets by day 5.

  5 days

Secondary Outcomes (5)

• By day 7, percentage of children recovered from diarrhea by the study diets

  7 days

• Frequency of stool in different days in different study diet groups

  7 days

• Consistency of stool in different days in different study diet groups

  7 days

• Number of hospital acquired infection (HAI) in different study diet groups

  7 days

• Rate of relapse within 14 days follow up

  14 days

Study Arms (3)

GB mixed full strength rice suji

EXPERIMENTAL

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 GB mixed full strength rice suji. The allocated 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: GB mixed full strength rice suji

Full strength rice suji alone

EXPERIMENTAL

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.

Other: Full strength rice suji Alone

3/4th strength rice suji

ACTIVE COMPARATOR

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.

Other: 3/4th strength rice suji

Interventions

GB mixed full strength rice suji OTHER

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.

GB mixed full strength rice suji

Full strength rice suji Alone OTHER

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.

Full strength rice suji alone

3/4th strength rice suji OTHER

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.

3/4th strength rice suji

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged \> 6 to 36 months, having diarrhea for 14 days or more (up to 29 days) either at admission or developed at some point during their treatment period in hospital
• Children able to take oral feeds at the time of randomization

You may not qualify if:

• Children whose parents/care givers do not provide consent
• Growth of Shigella, Salmonella or Cholera in rectal swab culture
• Children having WLZ/WHZ \< -5 SD or +++ edema
• The children presented with 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 and others that may itself cause digestive problem or failing to thrive
• Children diagnosed as having apparent or known tuberculosis or HIV or chronic (\> 30 days)/organic diarrhea (where the cause is known e.g. crohn's disease, ulcerative colitis, celiac disease etc.)

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Dhaka Hospital, icddr,b

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (1)

• Sarmin M, Hossain MI, Islam SB, Alam NH, Sarker SA, Islam MM, Chisti MJ, Islam SMR, Mahfuz M, Ahmed T. Efficacy of a Green Banana-Mixed Diet in the Management of Persistent Diarrhea: Protocol for an Open-Labeled, Randomized Controlled Trial. JMIR Res Protoc. 2020 Mar 6;9(3):e15759. doi: 10.2196/15759.

  PMID: 32224490 DERIVED

Study Officials

• Monira Sarmin, MBBS

  Medical officer, ICU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monira Sarmin, MBBS

CONTACT

01718596947; drmonira@icddrb.org

Md I Hossain, PhD

CONTACT

01711071075; ihossain@icdrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study design: This will be an open-labeled randomized controlled clinical trial with three treatment arms (3/4th strength rice suji, full strength rice suji with modification and GB mixed full strength rice suji). Investigators will prospectively screen, children \> 6 to 36 months of age admitted to the Dhaka hospital of icddr,b, with PD or developed PD during their treatment period and failed to respond with milk suji and enroll them for the study. Thereafter permuted block randomization technique will be followed to select treatment arms for each child.

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: December 8, 2017
• Study Start: December 7, 2017
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: February 18, 2021

Record last verified: 2020-10

Locations

BA (1)