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A Controlled Trial of Plantain Powder in Infantile Diarrhea

Primary Purpose

Diarrhea, Infantile

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Green banana powder
Microcrystalline cellulose
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea, Infantile focused on measuring diarrhea, Plantain, Green banana, Infants, Children

Eligibility Criteria

5 Months - 24 Months (Child)All SexesDoes not accept 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.

    -

Sites / Locations

  • Bhatpara Subdivisional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Green banana

Placebo

Arm Description

Subjects receiving green banana powder.

Microcrystalline cellulose given as placebo

Outcomes

Primary Outcome Measures

Frequency of stools per day.

Secondary Outcome Measures

Change in the consistency of stool.

Full Information

First Posted
August 8, 2008
Last Updated
August 5, 2011
Sponsor
Augusta University
Collaborators
NRS Medical College, Kolkata, West Bengal, India, School of Tropical Medicine, Kolkata, West Bengal, India
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1. Study Identification

Unique Protocol Identification Number
NCT00732732
Brief Title
A Controlled Trial of Plantain Powder in Infantile Diarrhea
Official Title
A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Augusta University
Collaborators
NRS Medical College, Kolkata, West Bengal, India, School of Tropical Medicine, Kolkata, West Bengal, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Infantile
Keywords
diarrhea, Plantain, Green banana, Infants, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Green banana
Arm Type
Experimental
Arm Description
Subjects receiving green banana powder.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Microcrystalline cellulose given as placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Green banana powder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Microcrystalline cellulose
Intervention Description
Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more
Primary Outcome Measure Information:
Title
Frequency of stools per day.
Time Frame
Daily for 10 days
Secondary Outcome Measure Information:
Title
Change in the consistency of stool.
Time Frame
Daily for 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital. Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject The consistency of the stool is such that it takes the shape of the container into which it is put in. Duration of symptoms should be less than 14 days. - Exclusion Criteria: Children with bloody diarrhea Children with lethargy, fever or other signs of septicemia Children with shock. Children unable to take medications orally. Children with impaired consciousness. Children whose parents refuse permission to be included in the study. Children who are not usual residents of the area and will not be available for follow up. Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tapas K Sabui, MD
Organizational Affiliation
NRS Medical College, Kolkata.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bhatpara Subdivisional Hospital
City
Bhatpara
State/Province
West Bengal
ZIP/Postal Code
N 24 pgs
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
15139502
Citation
Rabbani GH, Teka T, Saha SK, Zaman B, Majid N, Khatun M, Wahed MA, Fuchs GJ. Green banana and pectin improve small intestinal permeability and reduce fluid loss in Bangladeshi children with persistent diarrhea. Dig Dis Sci. 2004 Mar;49(3):475-84. doi: 10.1023/b:ddas.0000020507.25910.cf.
Results Reference
result
PubMed Identifier
11522739
Citation
Rabbani GH, Teka T, Zaman B, Majid N, Khatun M, Fuchs GJ. Clinical studies in persistent diarrhea: dietary management with green banana or pectin in Bangladeshi children. Gastroenterology. 2001 Sep;121(3):554-60. doi: 10.1053/gast.2001.27178.
Results Reference
result

Learn more about this trial

A Controlled Trial of Plantain Powder in Infantile Diarrhea

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