Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT00937274
First received: July 8, 2009
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

This study hopes to demonstrate the potentials of a new form of therapy for childhood diarrhea, a major cause of morbidity and deaths in Bangladesh and other developing countries, and thus a priority for improving child health.


Condition Intervention
Diarrhea
Other: T4 phage cocktail test
Other: Commercial T4 phage cocktail
Other: standard oral rehydration solution (ORS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind Placebo-controlled Studies to Evaluate the Effect of an Orally-fed Escherichia Coli (E. Coli) Phage in the Management of ETEC and EPEC Induced Diarrhea in Children

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Assessment of safety, tolerability and efficacy (reduce severity of diarrhea assessed by reduced stool volume and stool frequency) of oral administration of T4 phages in young children with diarrhea due to ETEC and/or EPEC infections [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical assessment, blood tests, morbidity, duration of hospitalization [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: August 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test product Other: T4 phage cocktail test
T4 phages 106 PFU/ ml up to 5 days
Active Comparator: Commercial product Other: Commercial T4 phage cocktail
Treatment as recommended by the manufacturer (Microgen phages)
Placebo Comparator: Standard care Other: standard oral rehydration solution (ORS)
Standard hospital treatment with ORS

Detailed Description:

This randomized double-blind, placebo controlled trial (RCT) aims to evaluate the effect of oral administered E. coli phage in children aged 4-60 months of age with proven ETEC and EPEC diarrhea. Children will be screened to exclude V. cholerae infections by dark field microscopy, rotavirus by stool ELISA, and invasive diarrhoea clinically as well as by stool microscopy, to identify children with possible ETEC and EPEC diarrhoea. Enrolled children will be randomly assigned, in equal numbers, to receive either: (i) a new T4 phage cocktail or (ii) Russian anti-E. coli phage cocktail (Microgen) at the dose recommended by the manufacturer or (iii) only oral rehydration solution (placebo) for 5 days in addition to management of dehydration and continued feeding in accordance with WHO guidelines. Duration of diarrhea, daily and cumulative stool output, volume of oral rehydration solution intake, stool frequency, time to recovery and weight gain will be the main outcome measures. As the dose of phage we intend to use in this therapeutic trial is higher than the dose administered to young children in earlier safety trial, we plan to initially conduct a safety study with these three study products in 45 children with non cholera, non rotavirus and non invasive diarrhea, to randomize equally in the three intervention groups, as for the final study mentioned above. The outcome measures in this safety part will include assessment of laboratory parameters including renal and liver function tests, haematological indices, and microbiological efficacy of phage by measuring phage and E. coli titre in daily stool samples. If the higher dose is found safe, tolerable, and not associated with any significant adverse event, we will proceed to the clinical efficacy trial.

We believe if T4 coli phage is assessed to be effective in the overall diarrhea management, this might lead to development of an affordable and sustainable adjunct to the currently available case management of E. coli diarrhea, benefiting millions of children worldwide.

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sex: male
  2. Age: 6 - 24 months
  3. Better nourished (weight for age > 60 NCHS median)
  4. H/o. diarrhea of less than 48 hours
  5. Written informed consent from either parents/guardian (thumb impression for those who are not literate) for children
  6. Negative test results for dark field microscopy of Vibrio cholerae and ELISA test for rotavirus in initial stool samples

Exclusion Criteria:

  1. Systemic infection requiring antibiotic treatment
  2. Severe malnutrition (W/A < 60%)
  3. Unwilling to comply with study procedures
  4. Currently participating or have participated in another clinical trial within the last 4 weeks at screening
  5. Clinically significant abnormalities from medical history, physical examination, vital signs, haematology, clinical chemistry results, or other laboratory abnormalities
  6. Clinically suggestive of invasive diarrhea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937274

Locations
Bangladesh
Clinical Sciences Division, ICDDR,B, Mohakhali,
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Shafiqul A Sarker, MD, PhD Clinical Sciences Division, ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00937274     History of Changes
Other Study ID Numbers: 08.11.INF
Study First Received: July 8, 2009
Last Updated: November 12, 2013
Health Authority: Bangladesh: Bangladesh Medical Research Council
Bangladesh: Ethical Review Committee

Keywords provided by Nestlé:
ETEC EPEC diarrhoea
phage therapy
ORS

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014