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A Controlled Trial of Plantain Powder in Infantile Diarrhea

NCT00732732 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2011-08-08

No results posted yet for this study

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.

Conditions

  • Diarrhea, Infantile

Interventions

DIETARY_SUPPLEMENT

Green 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.

OTHER

Microcrystalline cellulose

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

Sponsors & Collaborators

  • NRS Medical College, Kolkata, West Bengal, India

    collaborator UNKNOWN

  • School of Tropical Medicine, Kolkata, West Bengal, India

    collaborator OTHER

  • Augusta University

    lead OTHER

Principal Investigators

  • Tapas K Sabui, MD · NRS Medical College, Kolkata.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732732 on ClinicalTrials.gov