Acute DiarrheaPhase 4NCT01564290
Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
A Phase 4 study testing Probiotic yogurt in people with Acute Diarrhea and Acute Gastroenteritis, run by Centro Pediatrico Albina de Patino at 1 site in Bolivia.
Trial summary
The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products. Read more about this study
- Who is it for?
- Ages 10 to 36 months
- Conditions the study is for
- Acute Diarrhea, Acute Gastroenteritis
- What is being tested?
- Probiotic yogurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBolivia
- Study dates
- Feb 2011to Feb 2012
- Phase
- Phase 4
- 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 10 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All acute diarrhea
Who cannot join
- Severe malnourishment
- Severe dehydration
- Systemic infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial
The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.
Read the detailed description
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity.
Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.
- Conditions
- Acute Diarrhea, Acute Gastroenteritis
- Being tested
- Probiotic yogurt, Placebo probiotic
- Keywords
- acute diarrhea, probiotics, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic yogurtDietary supplement
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
Placebo probioticDrug
Also called Florestor
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| probiotic | Placebo comparator | Probiotic product with Sacharomices Boulardii Receives: Drug: Placebo probiotic |
| probiotic yogurt | Active comparator | Yogurt with Lactobacilus Rhamnonsus strain spp Receives: Dietary Supplement: Probiotic yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured: five days
Secondary outcomes (3)
Duration of fever
participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured: five days
duration of vomiting
participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured: five days
duration of hospitalization
participants will be followed for the duration of hospital stay, an expected average of 5 days
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Pediatrico Albina de Patino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Teran, Centro Pediatrico Albina de Patino
- Investigators
- Giuseppe E Grandy, MD MSc, Principal investigator, Centro Pediatrico Albina PatinoRichard M Soria, MD, Study director, Centro Pediatrico Albina PatinoSdenka Jose, MD, Study chair, Centro Pediatrico Albina Patino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564290
- Sponsor's protocol ID
- protprobiot2010
- Status last verified
- Mar 2012
- First submitted
- 29 Oct 2011
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT01564290
- Acronym / sponsor ID
- protprobiot2010
- Conditions
- Acute Diarrhea, Acute Gastroenteritis
- Keywords
- acute diarrhea, probiotics, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Centro Pediatrico Albina de PatinoUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 27 Mar 2012 (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.
The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.
Detailed description
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity.
Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic | Placebo comparator | Drug: Placebo probioticProbiotic product with Sacharomices Boulardii |
| probiotic yogurt | Active comparator | Dietary Supplement: Probiotic yogurtYogurt with Lactobacilus Rhamnonsus strain spp |
Who may qualify
- Ages
- 10 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All acute diarrhea
Key exclusion criteria (3 listed)
- Severe malnourishment
- Severe dehydration
- 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 |
|---|---|---|
| Probiotic yogurtLactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days. | Dietary supplement | probiotic yogurt |
| Placebo probioticAlso: FlorestorLyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days. | Drug | probiotic |
Primary outcome
Duration of diarrhea
Time frame: five days
participants will be followed for the duration of hospital stay, an expected average of 5 days
3 secondary outcomes
Duration of fever
Time frame: five days
duration of vomiting
Time frame: five days
duration of hospitalization
Time frame: five days
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 27 Mar 2012.
Related trials for Acute Diarrhea
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Acute Watery Diarrhea, Acute Watery Diarrhoea
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Hypernatremia Fluid Therapy in Childhood Diarrhoea
Hypernatremia, Acute Watery Diarrhea
Recruiting
Bacillus Clausii Versus Multistrain Probiotics for Acute Watery Diarrhea in Children
Acute Watery Diarrhea
Active, not recruiting
Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3
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Rural Water Filtration and Health Study
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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.
Giuseppe E Grandy, MD MSc principal investigator
Centro Pediatrico Albina Patino
Richard M Soria, MD study director
Centro Pediatrico Albina Patino
Sdenka Jose, MD study chair
Centro Pediatrico Albina Patino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic yogurt in people with Acute Diarrhea and Acute Gastroenteritis, 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 3 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 27 Mar 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: five days). 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 27 Mar 2012.