DiarrheaNCT00683982
Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
A study testing Nitazoxanide, Probiotic mix preparation and Oral hydration solutions in people with Diarrhea and Rotavirus Infection, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
Trial summary
Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus? Read more about this study
- Who is it for?
- Ages 28 days to 24 months
- Conditions the study is for
- Diarrhea, Rotavirus Infection
- What is being tested?
- Nitazoxanide, Probiotic mix preparation and Oral hydration solutions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBolivia
- Study dates
- Aug 2007to May 2008
- 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 28 days to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Positive stool sample for rotavirus test
Who cannot join
- Severe malnourishment
- Severe dehydration
- History of diarrhea more than 3 days previous hospitalization
- Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission
- Systemic infections
- Severe chronic disease
- Mixed enteric infections besides rotavirus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children
Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?
Read the detailed description
Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group
- Conditions
- Diarrhea, Rotavirus Infection
- Being tested
- Nitazoxanide, Probiotic mix preparation, Oral hydration solutions
- Keywords
- nitazoxanide, Probiotics, Diarrhea, Rotavirus, Children
- Medical subject headings
- Diarrhea, Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Noxom; Givotan
Nitazoxanide 15mg/Kg/day twice day for 3 days
Probiotic mix preparationDrug
Also called Probiotic
Probiotic preparation 1 gram twice a day for 5 days
Oral hydration solutionsOther
Also called Rehsal 60, 2.5% Glucosaline
Oral hydration solutions as needed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | This group will receive oral nitazoxanide preparation Receives: Drug: Nitazoxanide |
| 2 | Active comparator | This group will receive a mix combination of probiotics Receives: Drug: Probiotic mix preparation |
| 3 | Placebo comparator | This is the control group receiving only oral or systemic hydration solutions Receives: Other: Oral hydration solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
Measured: Hours
Secondary outcomes (1)
Duration of hospitalization
Measured: hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startAug 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Pediatrico Albina de Patino
- Sponsor type
- University, hospital or other
- Investigators
- Carlos N Teran, M.D, Study director, Centro Pediatrico Albina Patiño
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683982
- Sponsor's protocol ID
- PROT261179
- Other IDs
- PROT261179B
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 26 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children
- ClinicalTrials.gov ID
- NCT00683982
- Acronym / sponsor ID
- PROT261179
- Conditions
- Diarrhea, Rotavirus Infection
- Keywords
- nitazoxanide, Probiotics, Diarrhea, Rotavirus, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centro Pediatrico Albina de PatinoUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 26 May 2008 (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.
Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus?
Detailed description
Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: NitazoxanideThis group will receive oral nitazoxanide preparation |
| 2 | Active comparator | Drug: Probiotic mix preparationThis group will receive a mix combination of probiotics |
| 3 | Placebo comparator | Other: Oral hydration solutionsThis is the control group receiving only oral or systemic hydration solutions |
Who may qualify
- Ages
- 28 days to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Positive stool sample for rotavirus test
Key exclusion criteria (7 listed)
- Severe malnourishment
- Severe dehydration
- History of diarrhea more than 3 days previous hospitalization
- Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission
- Systemic infections
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 |
|---|---|---|
| NitazoxanideAlso: Noxom; GivotanNitazoxanide 15mg/Kg/day twice day for 3 days | Drug | 1 |
| Probiotic mix preparationAlso: ProbioticProbiotic preparation 1 gram twice a day for 5 days | Drug | 2 |
| Oral hydration solutionsAlso: Rehsal 60, 2.5% GlucosalineOral hydration solutions as needed | Other | 3 |
Primary outcome
Duration of diarrhea
Time frame: Hours
1 secondary outcome
Duration of hospitalization
Time frame: hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2008.
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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.
Carlos N Teran, M.D study director
Centro Pediatrico Albina Patiño
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitazoxanide, Probiotic mix preparation and Oral hydration solutions in people with Diarrhea and Rotavirus Infection, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 26 May 2008. 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 Bolivia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of diarrhea (time frame: Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2008.