Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight InfantsPhase 4NCT01411748
Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
A Phase 4 study testing Reflor and mikostatin in people with Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. Read more about this study
- Who is it for?
- Ages 1 day to 90 days
- Conditions the study is for
- Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants
- What is being tested?
- Reflor and mikostatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2011to Dec 2011
- 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 1 day to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very low birth weight infants < 1500 gr
Who cannot join
- Genetic anomalies
- Not willing to participate
- Allergy to S. boulardii components
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, 06230
Gamze Demirel, MD, +905324540156, kgamze@hotmail.com
Gamze Demirel, MD
About this study
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.
- Being tested
- Reflor, mikostatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReflorDietary supplement
5 million unit/day, orally, beginning on the second day of life, until discharge from hospital
mikostatinDrug
50000 unit/3 times a day, both for orally and by orogastric route
| Study group | Role | What they receive |
|---|---|---|
| S. boulardii | Experimental | The patients in this group will be given 5 million unit/day S. boulardii until discharge. Receives: Dietary Supplement: Reflor |
| nystatin | Active comparator | Not described Receives: Drug: mikostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
Measured: 6 months
Secondary outcomes (1)
Effect of S. boulardii on sepsis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight InfantsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411748
- Sponsor's protocol ID
- demirel98
- Status last verified
- Jul 2011
- First submitted
- 5 Aug 2011
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. doi: 10.1053/j.semperi.2007.01.006.
PubMed 17317426Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Lukaszewicz M. Capric acid secreted by S. boulardii inhibits C. albicans filamentous growth, adhesion and biofilm formation. PLoS One. 2010 Aug 10;5(8):e12050. doi: 10.1371/journal.pone.0012050.
PubMed 20706577
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Saccharomyces Boulardii and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01411748
- Acronym / sponsor ID
- demirel98
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 8 Aug 2011 (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.
Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Saccharomyces boulardii was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic S boulardii in reducing the candida colonization and infection in very low birth weight infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S. boulardii | Experimental | Dietary Supplement: ReflorThe patients in this group will be given 5 million unit/day S. boulardii until discharge. |
| nystatin | Active comparator | Drug: mikostatin |
Who may qualify
- Ages
- 1 day to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Very low birth weight infants < 1500 gr
Key exclusion criteria (3 listed)
- Genetic anomalies
- Not willing to participate
- Allergy to S. boulardii components
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 |
|---|---|---|
| Reflor5 million unit/day, orally, beginning on the second day of life, until discharge from hospital | Dietary supplement | S. boulardii |
| mikostatin50000 unit/3 times a day, both for orally and by orogastric route | Drug | nystatin |
Primary outcome
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants
Time frame: 6 months
1 secondary outcome
Effect of S. boulardii on sepsis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Background: PubMed 17317426Chapman RL. Prevention and treatment of Candida infections in neonates. Semin Perinatol. 2007 Feb;31(1):39-46. doi: 10.1053/j.semperi.2007.01.006.
- Background: PubMed 20706577Murzyn A, Krasowska A, Stefanowicz P, Dziadkowiec D, Lukaszewicz M. Capric acid secreted by S. boulardii inhibits C. albicans filamentous growth, adhesion and biofilm formation. PLoS One. 2010 Aug 10;5(8):e12050. doi: 10.1371/journal.pone.0012050.
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.
Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, Turkey (Türkiye)
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 Reflor and mikostatin in people with Anticandidal Property of Saccharomyces Boulardii on Very Low Birth Weight Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 8 Aug 2011. 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of prophylactic S. boulardii and nystatin on candida colonization and infection in very low birth weight infants (time frame: 6 months). 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 NCT01411748, which also lists 2 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 8 Aug 2011.