Isoleucine Added ORS in Children With Diarrhoea

NCT01034228 | Completed Phase 2 DMC

• 1 other identifier: 2006-018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Infectious Diarrhoea in Children

Keywords

Diarrhoea; L-isoleucine; children; ORS; Antibacterial peptide

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (1)

• 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)

  12 months

Study Arms (2)

Isoleucine

ACTIVE COMPARATOR

Glucose ORS with L-Isoleucine

Other: ORS + Isoleucine

ORS without Isoleucine

PLACEBO COMPARATOR

ORS without Isoleucine for the treatment of diarrhoea in children

Other: ORS without Isoleucine

Interventions

ORS + Isoleucine OTHER

ORS with Isolelucine for treatment of diarrhoeal in children

Isoleucine

ORS without Isoleucine OTHER

ORS without Isoleucine for the treatment of diarrhoea in children

ORS without Isoleucine

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 6 months-36 months
• Sex: only males, for precise separation of stool and urine
• History of diarrhoea duration of \<48 hours
• Dehydration: some

You may not qualify if:

• Diarrhoea due to Vibrio cholerae that requires antimicrobial therapy by dark field microscopy
• Dysentery (blood in stool), which requires antimicrobial therapy
• Concomitant infection(s) e.g. ARI, meningitis, and sepsis
• History of taking antibiotics for the current diarrhoea episode
• Severely malnourished children (Wt for length \< 70%) or patients with edema

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Georgetown University: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Dhaka Hospital, ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Alam NH, Raqib R, Ashraf H, Qadri F, Ahmed S, Zasloff M, Agerberth B, Salam MA, Gyr N, Meier R. L-isoleucine-supplemented oral rehydration solution in the treatment of acute diarrhoea in children: a randomized controlled trial. J Health Popul Nutr. 2011 Jun;29(3):183-90. doi: 10.3329/jhpn.v29i3.7864.

  PMID: 21766553 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

ORALIT; Isoleucine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 17, 2009
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 17, 2009

Record last verified: 2006-04

Locations

BA (1)