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Isoleucine Added ORS in Children With Diarrhoea

This study has been completed.
Sponsor:
Collaborators:
Georgetown University
University Hospital, Basel, Switzerland
Karolinska Institutet
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01034228
First received: December 16, 2009
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

Efforts are continuing to improve the efficacy of oral rehydration solution in terms of reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery). Antimicrobial peptides, produced by the epithelial cells, represent an important component of the innate immunity of all epithelial surfaces of the body including intestine. Induction of expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and not very expensive, and its addition to oral rehydration solution might help early clearance of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help establish normal bacterial populations in the intestine, and favourably impacts the severity and duration of diarrhoea in young children. If the results are found encouraging, a therapeutic trial with adequate sample size would be justified.


Condition Intervention Phase
Acute Infectious Diarrhoea in Children
 Other: ORS + Isoleucine
Other: ORS without Isoleucine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exploratory Study to Evaluate the Effect of L-isoleucine Supplemented Oral Rehydration Solution in the Treatment of Acute Diarrhoea in Children and in Inducing Innate Immunity

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea
Drug Information available for: Isoleucine
U.S. FDA Resources

Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • 1. Weight of abnormal (watery/liquid) stool for each 6-hour and 24-hour (day) of the study as well as cumulative weight until resolution of diarrhoea (maximum of 5 days) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. ORS intake in different time periods, for each 6-hour and 24-hour (day) of the study as well as cumulative weight until resolution of diarrhoea (maximum of 5 days) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isoleucine
Glucose ORS with L-Isoleucine
 Other: ORS + Isoleucine
ORS with Isolelucine for treatment of diarrhoeal in children
Placebo Comparator: ORS without Isoleucine
ORS without Isoleucine for the treatment of diarrhoea in children
 Other: ORS without Isoleucine
ORS without Isoleucine for the treatment of diarrhoea in children

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 6 months-36 months
  2. Sex: only males, for precise separation of stool and urine
  3. History of diarrhoea duration of <48 hours
  4. Dehydration: some

Exclusion Criteria:

  1. Diarrhoea due to Vibrio cholerae that requires antimicrobial therapy by dark field microscopy
  2. Dysentery (blood in stool), which requires antimicrobial therapy
  3. Concomitant infection(s) e.g. ARI, meningitis, and sepsis
  4. History of taking antibiotics for the current diarrhoea episode
  5. Severely malnourished children (Wt for length < 70%) or patients with edema
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034228

Locations
Bangladesh
Dhaka Hospital, ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Georgetown University
University Hospital, Basel, Switzerland
Karolinska Institutet
  More Information

No publications provided by International Centre for Diarrhoeal Disease Research, Bangladesh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01034228     History of Changes
Other Study ID Numbers: 2006-018
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Diarrhoea
L-isoleucine
children
ORS
Antibacterial peptide

Additional relevant MeSH terms:
Communicable Diseases
Infection
Diarrhea
Dysentery
Signs and Symptoms, Digestive
 Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013