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Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

NCT ID: NCT00937274

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Diarrhea

Keywords

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ETEC EPEC diarrhoea phage therapy ORS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test product

Group Type EXPERIMENTAL

T4 phage cocktail test

Intervention Type OTHER

T4 phages 106 PFU/ ml up to 5 days

Commercial product

Group Type ACTIVE_COMPARATOR

Commercial T4 phage cocktail

Intervention Type OTHER

Treatment as recommended by the manufacturer (Microgen phages)

Standard care

Group Type PLACEBO_COMPARATOR

standard oral rehydration solution (ORS)

Intervention Type OTHER

Standard hospital treatment with ORS

Interventions

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T4 phage cocktail test

T4 phages 106 PFU/ ml up to 5 days

Intervention Type OTHER

Commercial T4 phage cocktail

Treatment as recommended by the manufacturer (Microgen phages)

Intervention Type OTHER

standard oral rehydration solution (ORS)

Standard hospital treatment with ORS

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shafiqul A Sarker, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Sciences Division, ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh

Locations

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Clinical Sciences Division, ICDDR,B, Mohakhali,

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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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.

Reference Type DERIVED
PMID: 26981577 (View on PubMed)

Other Identifiers

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08.11.INF

Identifier Type: -

Identifier Source: org_study_id