ClinicalTrials.gov
ClinicalTrials.gov Menu

Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00937274
Recruitment Status : Terminated
First Posted : July 10, 2009
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
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 or disease Intervention/treatment Phase
Diarrhea Other: T4 phage cocktail test Other: Commercial T4 phage cocktail Other: standard oral rehydration solution (ORS) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical assessment, blood tests, morbidity, duration of hospitalization [ Time Frame: 5 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes 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

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT00937274     History of Changes
Other Study ID Numbers: 08.11.INF
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Nestlé:
ETEC EPEC diarrhoea
phage therapy
ORS

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Pharmaceutical Solutions