A Controlled Trial of Plantain Powder in Infantile Diarrhea

Not Applicable

Terminated

• Conditions: Diarrhea, Infantile
• Interventions: Dietary Supplement: Green banana powder; Other: Microcrystalline cellulose

• Registration Number: NCT00732732
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Study Start: 2008-09
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-05
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Green banana	Green banana powder	Subjects receiving green banana powder.
Placebo	Microcrystalline cellulose	Microcrystalline cellulose given as placebo

Primary Outcome Measures

Name	Time	Method
Frequency of stools per day.	Daily for 10 days

Secondary Outcome Measures

Name	Time	Method
Change in the consistency of stool.	Daily for 10 days

Trial Locations

Locations (1)

Bhatpara Subdivisional Hospital; 🇮🇳 Bhatpara, West Bengal, India