A Controlled Trial of Plantain Powder in Infantile Diarrhea

Diarrhea, Infantile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00732732
• Other study ID #: HAC 08-01-165
• Status: Terminated
• Phase: N/A
• First received: August 8, 2008
• Last updated: August 5, 2011
• Start date: September 2008
• Est. completion date: January 2010

Study information

• Verified date: August 2011
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Months to 24 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea, Infantile

Intervention

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.

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

Locations

Country	Name	City	State
India	Bhatpara Subdivisional Hospital	Bhatpara	West Bengal

Sponsors (3)

Lead Sponsor	Collaborator
Georgia Regents University	NRS Medical College, Kolkata, West Bengal, India, School of Tropical Medicine, Kolkata, West Bengal, India

Country where clinical trial is conducted

India, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of stools per day.		Daily for 10 days	No
Secondary	Change in the consistency of stool.		Daily for 10 days	No