Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children (GB in ProD)

NCT07848789 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: PR-26-062
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diarrhoeal Disease; Prolonged Diarrhea

Keywords

Green banana; Milk suzi; children; prolonged diarrhea

Outcome Measures

Primary Outcomes (1)

• • 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

  Within 5 days from randomization

Study Arms (2)

Milk suji

EXPERIMENTAL

milk suji

Drug: MS

Arm MS +GB

EXPERIMENTAL

milk + GB

Drug: MS +GB

Interventions

MS DRUG

Standard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml.

Milk suji

MS +GB DRUG

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)

Arm MS +GB

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Dhaka Hospital, icddr,b

Dhaka, Dhaka Division, 1212, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both A and B coded diets (GB and control) look almost similar as a thick, white, homogenous suspension, without substantial variation in test, color, and smell.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Children will randomly receive either Green Banana (GB) mixed diet (n=52) or milk suji diet (n=52). The children, mothers/caregivers and the research physician/other research staff will be blinded about the type of diet. The allocation of diet will be coded as "A" or "B" (any one for GB diet and the other for milk suji diet) with a block length of four by an independent scientist.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 30, 2026
• Study Start: September 13, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)