GastroenteritisNCT02080130
Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea
A study testing Saccharomyces boulardii and Probiotics combination in people with Gastroenteritis, run by Sinaloa Pediatric Hospital at 1 site in Mexico.
Trial summary
The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Saccharomyces boulardii and Probiotics combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2014to Dec 2016
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of acute viral gastroenteritis
Who cannot join
- Moderate or severe dehydration
- Malnutrition
- Immunodeficiencies
- Sepsis or bacterial infection
- Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
- Hospitalisation
- No phone number
- Illiteracy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial
The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.
Read the detailed description
Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.
- Conditions
- Gastroenteritis
- Being tested
- Saccharomyces boulardii, Probiotics combination, Placebo
- Keywords
- Gastroenteritis, diarrhea
- Medical subject headings
- Gastroenteritis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saccharomyces boulardiiDietary supplement
FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
Probiotics combinationDietary supplement
LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces boulardii | Experimental | FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days. Receives: Dietary Supplement: Saccharomyces boulardii |
| Probiotics combination | Experimental | LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu Receives: Dietary Supplement: Probiotics combination |
| Placebo | Placebo comparator | Placebo sachet. One sachet orally, BID, for 5 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhoea in hours
Measured: Up to 7 days
Secondary outcomes (3)
Percentage of children requiring hospitalisation
Measured: Up to 7 days
Adverse effects
Measured: Up to 7 days
Number of liquid stools
Measured: Up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: No participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinaloa Pediatric Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giordano Perez Gaxiola, Sinaloa Pediatric Hospital
- Investigators
- Giordano Pérez-Gaxiola, MD, Study chair, Sinaloa Pediatric Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080130
- Sponsor's protocol ID
- HPS-03
- Status last verified
- Sep 2018
- First submitted
- 4 Mar 2014
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Probiotic Preparations in Children With Acute Viral Diarrhoea, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02080130
- Acronym / sponsor ID
- HPS-03
- Conditions
- Gastroenteritis
- Keywords
- Gastroenteritis, diarrhea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sinaloa Pediatric HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Mar 2014 (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 which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.
Detailed description
Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces boulardii | Experimental | Dietary Supplement: Saccharomyces boulardiiFLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days. |
| Probiotics combination | Experimental | Dietary Supplement: Probiotics combinationLACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu |
| Placebo | Placebo comparator | Other: PlaceboPlacebo sachet. One sachet orally, BID, for 5 days. |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute viral gastroenteritis
Key exclusion criteria (8 listed)
- Moderate or severe dehydration
- Malnutrition
- Immunodeficiencies
- Sepsis or bacterial infection
- Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
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 |
|---|---|---|
| Saccharomyces boulardiiFLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days. | Dietary supplement | Saccharomyces boulardii |
| Probiotics combinationLACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu | Dietary supplement | Probiotics combination |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Duration of diarrhoea in hours
Time frame: Up to 7 days
3 secondary outcomes
Percentage of children requiring hospitalisation
Time frame: Up to 7 days
Adverse effects
Time frame: Up to 7 days
Number of liquid stools
Time frame: Up to seven days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
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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.
Giordano Pérez-Gaxiola, MD study chair
Sinaloa Pediatric Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saccharomyces boulardii and Probiotics combination in people with Gastroenteritis, run by Sinaloa Pediatric Hospital at 1 site in Mexico.
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 8 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: withdrawn, as of the sponsor's last update on 6 Sep 2018. 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 Mexico. 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 withdrawn before enrolling participants, so there are no results.
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 diarrhoea in hours (time frame: Up to 7 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 6 Sep 2018.