DiarrheaNCT00937274
Antibacterial Treatment Against Diarrhea in Oral Rehydration Solution
A study testing T4 phage cocktail test, Commercial T4 phage cocktail and standard oral rehydration solution (ORS) in people with Diarrhea, run by Société des Produits Nestlé (SPN) at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 months, men only
- Conditions the study is for
- Diarrhea
- What is being tested?
- T4 phage cocktail test, Commercial T4 phage cocktail and standard oral rehydration solution (ORS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBangladesh
- Study dates
- Aug 2009to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Clinical Sciences Division, ICDDR,B, Mohakhali,
Dhaka, 1212
About this study
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
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.
Read the 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.
- Conditions
- Diarrhea
- Being tested
- T4 phage cocktail test, Commercial T4 phage cocktail, standard oral rehydration solution (ORS)
- Keywords
- ETEC EPEC diarrhoea, phage therapy, ORS
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T4 phage cocktail testOther
T4 phages 106 PFU/ ml up to 5 days
Commercial T4 phage cocktailOther
Treatment as recommended by the manufacturer (Microgen phages)
standard oral rehydration solution (ORS)Other
Standard hospital treatment with ORS
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Not described Receives: Other: T4 phage cocktail test |
| Commercial product | Active comparator | Not described Receives: Other: Commercial T4 phage cocktail |
| Standard care | Placebo comparator | Not described Receives: Other: standard oral rehydration solution (ORS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Secondary outcomes (1)
Clinical assessment, blood tests, morbidity, duration of hospitalization
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shafiqul A Sarker, MD, PhD, Principal investigator, Clinical Sciences Division, ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937274
- Sponsor's protocol ID
- 08.11.INF
- Status last verified
- Nov 2013
- First submitted
- 8 Jul 2009
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26981577
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00937274
- Acronym / sponsor ID
- 08.11.INF
- Conditions
- Diarrhea
- Keywords
- ETEC EPEC diarrhoea, phage therapy, ORS
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T4 phage cocktail testT4 phages 106 PFU/ ml up to 5 days | Other | Test product |
| Commercial T4 phage cocktailTreatment as recommended by the manufacturer (Microgen phages) | Other | Commercial product |
| standard oral rehydration solution (ORS)Standard hospital treatment with ORS | Other | Standard care |
Primary outcome
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
1 secondary outcome
Clinical assessment, blood tests, morbidity, duration of hospitalization
Time frame: 5 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 26981577Sarker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafiqul A Sarker, MD, PhD principal investigator
Clinical Sciences Division, ICDDR,B, Mohakhali, Dhaka 1212, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T4 phage cocktail test, Commercial T4 phage cocktail and standard oral rehydration solution (ORS) in people with Diarrhea, run by Société des Produits Nestlé (SPN) at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00937274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.