A Controlled Trial of Plantain Powder in Infantile Diarrhea

A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00732732

Enrollment

200

Registered

2008-08-12

Start date

2008-09-30

Completion date

2010-01-31

Last updated

2011-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Infantile

Keywords

diarrhea, Plantain, Green banana, Infants, Children

Brief summary

Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea. The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea. Infants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study). Two hundred patients will be enrolled in 24 months.

Interventions

DIETARY_SUPPLEMENTGreen banana powder

Green banana in powder form, 10 grams/ day for children below 10 kg, 20 grams for those weighing 10 Kg or more. Protocol Modified on Aug 5th 2009 to give 20 grams irrespective of age.

OTHERMicrocrystalline cellulose

Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Months to 24 Months

Healthy volunteers

Inclusion criteria

1. Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital. 2. Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject 3. The consistency of the stool is such that it takes the shape of the container into which it is put in. 4. Duration of symptoms should be less than 14 days. \-

Exclusion criteria

1. Children with bloody diarrhea 2. Children with lethargy, fever or other signs of septicemia 3. Children with shock. 4. Children unable to take medications orally. 5. Children with impaired consciousness. 6. Children whose parents refuse permission to be included in the study. 7. Children who are not usual residents of the area and will not be available for follow up. 8. Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc. \-

Design outcomes

Primary

Measure	Time frame
Frequency of stools per day.	Daily for 10 days

Secondary

Measure	Time frame
Change in the consistency of stool.	Daily for 10 days

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026