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A Controlled Trial of Plantain Powder in Infantile Diarrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00732732
Recruitment Status : Terminated (Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.)
First Posted : August 12, 2008
Last Update Posted : August 8, 2011
NRS Medical College, Kolkata, West Bengal, India
School of Tropical Medicine, Kolkata, West Bengal, India
Information provided by:
Augusta University

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.

Condition or disease Intervention/treatment Phase
Diarrhea, Infantile Dietary Supplement: Green banana powder Other: Microcrystalline cellulose Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
Study Start Date : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

Primary Outcome Measures :
  1. Frequency of stools per day. [ Time Frame: Daily for 10 days ]

Secondary Outcome Measures :
  1. Change in the consistency of stool. [ Time Frame: Daily for 10 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00732732

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Bhatpara Subdivisional Hospital
Bhatpara, West Bengal, India, N 24 pgs
Sponsors and Collaborators
Augusta University
NRS Medical College, Kolkata, West Bengal, India
School of Tropical Medicine, Kolkata, West Bengal, India
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Principal Investigator: Tapas K Sabui, MD NRS Medical College, Kolkata.
Publications of Results:
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Responsible Party: Sudipta Misra MD, Professor of Pediatrics, Medical College of Georgia Identifier: NCT00732732    
Other Study ID Numbers: HAC 08-01-165
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: August 2011
Keywords provided by Augusta University:
Green banana
Additional relevant MeSH terms:
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Diarrhea, Infantile
Signs and Symptoms, Digestive
Signs and Symptoms