Clinical trial NCT00732732: A Controlled Trial of Plantain Powder in Infantile Diarrhea
Official title: A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diarrhea, Infantile
Keywords: diarrhea
Plantain
Green banana
Infants
Children
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: NRS Medical College, Kolkata, West Bengal, India
name: School of Tropical Medicine, Kolkata, West Bengal, India
First posted: 2008-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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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.

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Primary outcomes:
measure: Frequency of stools per day.
timeFrame: Daily for 10 days
Secondary outcomes:
measure: Change in the consistency of stool.
timeFrame: Daily for 10 days
Other outcomes:
Locations:
city: Bhatpara
country: India
facility: Bhatpara Subdivisional Hospital
state: West Bengal
Study officials:
affiliation: NRS Medical College, Kolkata.
name: Tapas K Sabui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1053/gast.2001.27178.