DiarrheaNCT00981877
Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
A study testing GB (Florestor) and GRALB in people with Diarrhea and Rotavirus Infection, 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 probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products. Read more about this study
- Who is it for?
- Ages 1 month to 23 months
- Conditions the study is for
- Diarrhea, Rotavirus Infection
- What is being tested?
- GB (Florestor) and GRALB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteBolivia
- Study dates
- Jul 2007to Mar 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 1 month to 23 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
- Use of antibiotics, probiotics or nitazoxanide 2 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: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.
Read the detailed description
Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.
- Conditions
- Diarrhea, Rotavirus Infection
- Being tested
- GB (Florestor), GRALB, GC (placebo)
- Keywords
- acute diarrhea, rotavirus, probiotic, 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.
GB (Florestor)Drug
Also called Florestor, Bioflora
- Boulardii preparation of 1 gram twice daily for 5 days
GRALBDrug
Also called Probiotik, mixed probiotic
mixed probiotic preparation 1 gram twice daily for 5 days.
GC (placebo)Drug
Also called Placebo
Placebo 1 gram twice daily for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | This group will receive S. Boulardii Probiotic and Oral rehydration as needed Receives: Drug: GB (Florestor) |
| 2 | Active comparator | This group will receive a mixed Probiotic preparation and oral rehydration as needed Receives: Drug: GRALB |
| 3 | Placebo comparator | This group will receive a placebo, and oral rehydration as needed Receives: Drug: GC (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
Measured: within the first 72 hours during hospitalization
Secondary outcomes (3)
Duration of fever
Measured: the first 72 hours during hospitalization
Duration of vomiting
Measured: the first 72 hours during hospitalization
Duration of hospitalization
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startJul 2007
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Pediatrico Albina de Patino
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Nutrición y Tecnología de los Alimentos
- Investigators
- Richard M Soria, MD, Study director, Centro Pediatrico Albina PatinoGiuseppe E Grandy, Md, Principal investigator, Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981877
- Sponsor's protocol ID
- protrota2007
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Smithline HA, Donnino M, Greenblatt DJ. Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects. BMC Clin Pharmacol. 2012 Feb 4;12:4. doi: 10.1186/1472-6904-12-4.
PubMed 22305197Waldvogel S, Pedrazzini B, Vaucher P, Bize R, Cornuz J, Tissot JD, Favrat B. Clinical evaluation of iron treatment efficiency among non-anemic but iron-deficient female blood donors: a randomized controlled trial. BMC Med. 2012 Jan 24;10:8. doi: 10.1186/1741-7015-10-8.
PubMed 22272750Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial. Trials. 2012 Jan 16;13:10. doi: 10.1186/1745-6215-13-10.
PubMed 22243622Wiseman V, Mangham LJ, Cundill B, Achonduh OA, Nji AM, Njei AN, Chandler C, Mbacham WF. A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a randomized controlled trial. Trials. 2012 Jan 6;13:4. doi: 10.1186/1745-6215-13-4.
PubMed 22225699Husebye EE, Lyberg T, Opdahl H, Aspelin T, Stoen RO, Madsen JE, Roise O. Intramedullary nailing of femoral shaft fractures in polytraumatized patients. a longitudinal, prospective and observational study of the procedure-related impact on cardiopulmonary- and inflammatory responses. Scand J Trauma Resusc Emerg Med. 2012 Jan 5;20:2. doi: 10.1186/1757-7241-20-2.
PubMed 22221511Pontes-Arruda A, Martins LF, de Lima SM, Isola AM, Toledo D, Rezende E, Maia M, Magnan GB; Investigating Nutritional Therapy with EPA, GLA and Antioxidants Role in Sepsis Treatment (INTERSEPT) Study Group. Enteral nutrition with eicosapentaenoic acid, gamma-linolenic acid and antioxidants in the early treatment of sepsis: results from a multicenter, prospective, randomized, double-blinded, controlled study: the INTERSEPT study. Crit Care. 2011 Jun 9;15(3):R144. doi: 10.1186/cc10267.
PubMed 21658240Grandy G, Medina M, Soria R, Teran CG, Araya M. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children. BMC Infect Dis. 2010 Aug 25;10:253. doi: 10.1186/1471-2334-10-253.
PubMed 20735858
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
- ClinicalTrials.gov ID
- NCT00981877
- Acronym / sponsor ID
- protrota2007
- Conditions
- Diarrhea, Rotavirus Infection
- Keywords
- acute diarrhea, rotavirus, probiotic, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centro Pediatrico Albina de PatinoUniversity, hospital or other
- Collaborators
- Instituto de Nutrición y Tecnología de los Alimentos
- Study start
- Jul 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Sep 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.
The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.
Detailed description
Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GB (Florestor)This group will receive S. Boulardii Probiotic and Oral rehydration as needed |
| 2 | Active comparator | Drug: GRALBThis group will receive a mixed Probiotic preparation and oral rehydration as needed |
| 3 | Placebo comparator | Drug: GC (placebo)This group will receive a placebo, and oral rehydration as needed |
Who may qualify
- Ages
- 1 month to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Positive stool sample for rotavirus test
Key exclusion criteria (6 listed)
- Severe malnourishment
- Severe dehydration
- Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
- Systemic infections
- Severe chronic disease
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 |
|---|---|---|
| GB (Florestor)Also: Florestor, BiofloraS. Boulardii preparation of 1 gram twice daily for 5 days | Drug | 1 |
| GRALBAlso: Probiotik, mixed probioticmixed probiotic preparation 1 gram twice daily for 5 days. | Drug | 2 |
| GC (placebo)Also: PlaceboPlacebo 1 gram twice daily for 5 days. | Drug | 3 |
Primary outcome
Duration of diarrhea
Time frame: within the first 72 hours during hospitalization
3 secondary outcomes
Duration of fever
Time frame: the first 72 hours during hospitalization
Duration of vomiting
Time frame: the first 72 hours during hospitalization
Duration of hospitalization
Time frame: 4 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 22 Sep 2009.
- Derived from this study: PubMed 22305197Smithline HA, Donnino M, Greenblatt DJ. Pharmacokinetics of high-dose oral thiamine hydrochloride in healthy subjects. BMC Clin Pharmacol. 2012 Feb 4;12:4. doi: 10.1186/1472-6904-12-4.
- Derived from this study: PubMed 22272750Waldvogel S, Pedrazzini B, Vaucher P, Bize R, Cornuz J, Tissot JD, Favrat B. Clinical evaluation of iron treatment efficiency among non-anemic but iron-deficient female blood donors: a randomized controlled trial. BMC Med. 2012 Jan 24;10:8. doi: 10.1186/1741-7015-10-8.
- Derived from this study: PubMed 22243622Savolainen-Kopra C, Haapakoski J, Peltola PA, Ziegler T, Korpela T, Anttila P, Amiryousefi A, Huovinen P, Huvinen M, Noronen H, Riikkala P, Roivainen M, Ruutu P, Teirila J, Vartiainen E, Hovi T. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial. Trials. 2012 Jan 16;13:10. doi: 10.1186/1745-6215-13-10.
- Derived from this study: PubMed 22225699Wiseman V, Mangham LJ, Cundill B, Achonduh OA, Nji AM, Njei AN, Chandler C, Mbacham WF. A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a randomized controlled trial. Trials. 2012 Jan 6;13:4. doi: 10.1186/1745-6215-13-4.
- Derived from this study: PubMed 22221511Husebye EE, Lyberg T, Opdahl H, Aspelin T, Stoen RO, Madsen JE, Roise O. Intramedullary nailing of femoral shaft fractures in polytraumatized patients. a longitudinal, prospective and observational study of the procedure-related impact on cardiopulmonary- and inflammatory responses. Scand J Trauma Resusc Emerg Med. 2012 Jan 5;20:2. doi: 10.1186/1757-7241-20-2.
- Derived from this study: PubMed 21658240Pontes-Arruda A, Martins LF, de Lima SM, Isola AM, Toledo D, Rezende E, Maia M, Magnan GB; Investigating Nutritional Therapy with EPA, GLA and Antioxidants Role in Sepsis Treatment (INTERSEPT) Study Group. Enteral nutrition with eicosapentaenoic acid, gamma-linolenic acid and antioxidants in the early treatment of sepsis: results from a multicenter, prospective, randomized, double-blinded, controlled study: the INTERSEPT study. Crit Care. 2011 Jun 9;15(3):R144. doi: 10.1186/cc10267.
- Derived from this study: PubMed 20735858Grandy G, Medina M, Soria R, Teran CG, Araya M. Probiotics in the treatment of acute rotavirus diarrhoea. A randomized, double-blind, controlled trial using two different probiotic preparations in Bolivian children. BMC Infect Dis. 2010 Aug 25;10:253. doi: 10.1186/1471-2334-10-253.
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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.
Richard M Soria, MD study director
Centro Pediatrico Albina Patino
Giuseppe E Grandy, Md principal investigator
Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GB (Florestor) and GRALB 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 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: finished, as of the sponsor's last update on 22 Sep 2009. 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: within the first 72 hours during hospitalization). 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 NCT00981877, which also lists 7 linked publications.
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 22 Sep 2009.