A Controlled Trial of Plantain Powder in Infantile Diarrhea

Augusta University

Status: Terminated

Conditions: Diarrhea, Infantile

Treatments: Dietary Supplement: Green banana powder; Other: Microcrystalline cellulose

Study type: Interventional

Funder types: Other

Identifiers

NCT00732732

HAC 08-01-165

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 5 to 24 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups, including a placebo group

Green banana

Experimental group

Description:

Subjects receiving green banana powder.

Treatment:

Dietary Supplement: Green banana powder

Placebo

Placebo Comparator group

Description:

Microcrystalline cellulose given as placebo

Treatment:

Other: Microcrystalline cellulose