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Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

Primary Purpose

Diarrhea

Status
Terminated
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
T4 phage cocktail test
Commercial T4 phage cocktail
standard oral rehydration solution (ORS)
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring ETEC EPEC diarrhoea, phage therapy, ORS

Eligibility Criteria

6 Months - 24 Months (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Sciences Division, ICDDR,B, Mohakhali,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test product

Commercial product

Standard care

Arm Description

Outcomes

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

Secondary Outcome Measures

Clinical assessment, blood tests, morbidity, duration of hospitalization

Full Information

First Posted
July 8, 2009
Last Updated
November 12, 2013
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT00937274
Brief Title
Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
ETEC EPEC diarrhoea, phage therapy, ORS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test product
Arm Type
Experimental
Arm Title
Commercial product
Arm Type
Active Comparator
Arm Title
Standard care
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
T4 phage cocktail test
Intervention Description
T4 phages 106 PFU/ ml up to 5 days
Intervention Type
Other
Intervention Name(s)
Commercial T4 phage cocktail
Intervention Description
Treatment as recommended by the manufacturer (Microgen phages)
Intervention Type
Other
Intervention Name(s)
standard oral rehydration solution (ORS)
Intervention Description
Standard hospital treatment with ORS
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Clinical assessment, blood tests, morbidity, duration of hospitalization
Time Frame
5 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sex: male Age: 6 - 24 months Better nourished (weight for age > 60 NCHS median) H/o. diarrhea of less than 48 hours Written informed consent from either parents/guardian (thumb impression for those who are not literate) for children Negative test results for dark field microscopy of Vibrio cholerae and ELISA test for rotavirus in initial stool samples Exclusion Criteria: Systemic infection requiring antibiotic treatment Severe malnutrition (W/A < 60%) Unwilling to comply with study procedures Currently participating or have participated in another clinical trial within the last 4 weeks at screening Clinically significant abnormalities from medical history, physical examination, vital signs, haematology, clinical chemistry results, or other laboratory abnormalities Clinically suggestive of invasive diarrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shafiqul A Sarker, MD, PhD
Organizational Affiliation
Clinical Sciences Division, ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Sciences Division, ICDDR,B, Mohakhali,
City
Dhaka
ZIP/Postal Code
1212
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
26981577
Citation
Sarker SA, Sultana S, Reuteler G, Moine D, Descombes P, Charton F, Bourdin G, McCallin S, Ngom-Bru C, Neville T, Akter M, Huq S, Qadri F, Talukdar K, Kassam M, Delley M, Loiseau C, Deng Y, El Aidy S, Berger B, Brussow H. Oral Phage Therapy of Acute Bacterial Diarrhea With Two Coliphage Preparations: A Randomized Trial in Children From Bangladesh. EBioMedicine. 2016 Jan 5;4:124-37. doi: 10.1016/j.ebiom.2015.12.023. eCollection 2016 Feb.
Results Reference
derived

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Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

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