A Controlled Trial of Plantain Powder in Infantile Diarrhea

This study has been terminated.
(Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.)
Sponsor:
Collaborators:
NRS Medical College, Kolkata, West Bengal, India
School of Tropical Medicine, Kolkata, West Bengal, India
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00732732
First received: August 8, 2008
Last updated: August 5, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Diarrhea, Infantile
Dietary Supplement: Green banana powder
Other: Microcrystalline cellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.

Resource links provided by NLM:


Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • Frequency of stools per day. [ Time Frame: Daily for 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the consistency of stool. [ Time Frame: Daily for 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732732

Locations
India
Bhatpara Subdivisional Hospital
Bhatpara, West Bengal, India, N 24 pgs
Sponsors and Collaborators
Georgia Regents University
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.
  More Information

Publications:
Responsible Party: Sudipta Misra MD, Professor of Pediatrics, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00732732     History of Changes
Other Study ID Numbers: HAC 08-01-165
Study First Received: August 8, 2008
Last Updated: August 5, 2011
Health Authority: India: Institutional Review Board
United States: Institutional Review Board

Keywords provided by Georgia Regents University:
diarrhea
Plantain
Green banana
Infants
Children

Additional relevant MeSH terms:
Diarrhea
Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014