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Isoleucine Added ORS in Children With Diarrhoea

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ClinicalTrials.gov Identifier: NCT01034228
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : December 17, 2009
Sponsor:
Collaborators:
Georgetown University
University Hospital, Basel, Switzerland
Karolinska Institutet
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh

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.

Condition or disease Intervention/treatment Phase
Acute Infectious Diarrhoea in Children Other: ORS + Isoleucine Other: ORS without Isoleucine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
Drug Information available for: Isoleucine

Arm Intervention/treatment
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




Primary Outcome Measures :
  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) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034228


Locations
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01034228    
Other Study ID Numbers: 2006-018
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: December 17, 2009
Last Verified: April 2006
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Diarrhoea
L-isoleucine
children
ORS
Antibacterial peptide
Additional relevant MeSH terms:
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Dysentery
Diarrhea
Signs and Symptoms, Digestive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases