Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution

NCT00937274 | Terminated

• 1 other identifier: 08.11.INF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

ETEC EPEC diarrhoea; phage therapy; ORS

Outcome Measures

Primary Outcomes (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

  5 days

Secondary Outcomes (1)

• Clinical assessment, blood tests, morbidity, duration of hospitalization

  5 days

Study Arms (3)

Test product

EXPERIMENTAL

Other: T4 phage cocktail test

Commercial product

ACTIVE COMPARATOR

Other: Commercial T4 phage cocktail

Standard care

PLACEBO COMPARATOR

Other: standard oral rehydration solution (ORS)

Interventions

T4 phage cocktail test OTHER

T4 phages 106 PFU/ ml up to 5 days

Test product

Commercial T4 phage cocktail OTHER

Treatment as recommended by the manufacturer (Microgen phages)

Commercial product

standard oral rehydration solution (ORS) OTHER

Standard hospital treatment with ORS

Standard care

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Clinical Sciences Division, ICDDR,B, Mohakhali,

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 26981577 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shafiqul A Sarker, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 10, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

BA (1)