A Controlled Trial of Plantain Powder in Infantile Diarrhea

August 5, 2011 updated by: Augusta University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Bhatpara, West Bengal, India, N 24 pgs
        • Bhatpara Subdivisional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Green banana
Subjects receiving green banana powder.
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.
Placebo Comparator: Placebo
Microcrystalline cellulose given as placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of stools per day.
Time Frame: Daily for 10 days
Daily for 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the consistency of stool.
Time Frame: Daily for 10 days
Daily for 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

NRS Medical College, Kolkata, West Bengal, India
School of Tropical Medicine, Kolkata, West Bengal, India

Investigators

  • Principal Investigator: Tapas K Sabui, MD, NRS Medical College, Kolkata.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimate)

August 12, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAC 08-01-165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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