NCT00732732

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

August 8, 2008

Last Update Submit

August 5, 2011

Conditions

Diarrhea, Infantile

Keywords

diarrheaPlantainGreen bananaInfantsChildren

Outcome Measures

Primary Outcomes (1)

  • Frequency of stools per day.

    Daily for 10 days

Secondary Outcomes (1)

  • Change in the consistency of stool.

    Daily for 10 days

Study Arms (2)

Green banana

EXPERIMENTAL

Subjects receiving green banana powder.

Dietary Supplement: Green banana powder

Placebo

PLACEBO COMPARATOR

Microcrystalline cellulose given as placebo

Other: Microcrystalline cellulose

Interventions

Green banana powderDIETARY_SUPPLEMENT

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.

Green banana
Microcrystalline celluloseOTHER

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

Placebo

Eligibility Criteria

Age5 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bhatpara Subdivisional Hospital

Bhātpāra, West Bengal, N 24 pgs, India

Location

Related Publications (2)

  • 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.

    PMID: 15139502RESULT

  • 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.

    PMID: 11522739RESULT

MeSH Terms

Conditions

Diarrhea, InfantileDiarrhea

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tapas K Sabui, MD

    NRS Medical College, Kolkata.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 8, 2011

Record last verified: 2011-08

Locations

IN(1)