Diarrhoeal DiseasePhase 2GB in ProDNCT07848789
Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children (GB in ProD)
A Phase 2 study testing MS and MS +GB in people with Diarrhoeal Disease and Prolonged Diarrhea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Diarrhoeal Disease, Prolonged Diarrhea
- What is being tested?
- MS and MS +GB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteBangladesh
- Study dates
- 13 Sep 2026to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Dhaka Hospital, icddr,b
Dhaka, Dhaka Division, 1212
Shamima Sultana, MBBS, MPH, +8801715151404, shamima@icddrb.org
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diarrhoeal Disease, Prolonged Diarrhea
- Being tested
- MS, MS +GB
- Keywords
- Green banana, Milk suzi, children, prolonged diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSDrug
Standard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml.
MS +GBDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Milk suji | Experimental | milk suji Receives: Drug: MS |
| Arm MS +GB | Experimental | milk + GB Receives: Drug: MS +GB |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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
Measured: Within 5 days from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start13 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhoeal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848789
- Sponsor's protocol ID
- PR-26-062
- Acronym
- GB in ProD
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Efficacy Trial of Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children
- ClinicalTrials.gov ID
- NCT07848789
- Acronym / sponsor ID
- GB in ProD / PR-26-062
- Conditions
- Diarrhoeal Disease, Prolonged Diarrhea
- Keywords
- Green banana, Milk suzi, children, prolonged diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 13 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Milk suji | Experimental | Drug: MSmilk suji |
| Arm MS +GB | Experimental | Drug: MS +GBmilk + GB |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSStandard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml. | Drug | Milk suji |
| MS +GBInvestigators 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) | Drug | Arm MS +GB |
Primary outcome
• Primary outcome: Clinical cure or Cessation of diarrhea
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MS and MS +GB in people with Diarrhoeal Disease and Prolonged Diarrhea, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Primary outcome: Clinical cure or Cessation of diarrhea (time frame: Within 5 days from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.