Very Low Birth Weight InfantsPhase 4NCT01531192

Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

A Phase 4 study testing Lactobacillus reuteri and Nystatin in people with Very Low Birth Weight Infants, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 day to 6 months
Conditions the study is for: Very Low Birth Weight Infants
What is being tested?: Lactobacillus reuteri and Nystatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Jun 2012to Apr 2013
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 6 months
All sexes
No healthy volunteers
Child

Who may be able to join

Very low birth weight infants < 1500 gr
Gestational age < 32 weeks

Who cannot join

Genetic anomalies
Short bowel syndrome
Not willing to participate
Allergy to Lactobacillus reuteri components

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology
Ankara, 06110

Other trials in Turkey (Türkiye)

About this study

Official title: Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey

Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida colonization. The objective of this study is to evaluate the efficacy of prophylactic Lactobacillus reuteri in reducing the candida colonization and infection in very low birth weight infants.

Conditions: Very Low Birth Weight Infants
Being tested: Lactobacillus reuteri, Nystatin
Keywords: Lactobacillus reuteri, Nystatin, Very Low Birth Weight Infants, Candida Colonization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lactobacillus reuteriDietary supplement
Also called BioGaia
Lactobacillus reuteri 100 million CFU/day for 3 months
NystatinDrug
Also called Mikostatin
50000 unit/3 times a day, both for orally and by orogastric route

Study groups in NCT01531192
Study group	Role	What they receive
Lactobacillus reuteri	Experimental	Lactobacillus reuteri 100 million CFU/day for 3 months Receives: Dietary Supplement: Lactobacillus reuteri
Nystatin	Active comparator	50000 unit/3 times a day Receives: Drug: Nystatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.
Measured: up to 6 months

Secondary outcomes (4)

Effect of Lactobacillus reuteri on feeding intolerance
Feeding intolerance (gastric residuals in the amount that was more than half of the previous feeding, abdominal distention or heme-positive stools)
Measured: up to 6 months
Effect of Lactobacillus reuteri on sepsis
Patients with culture positivity will accept as proven sepsis.
Measured: up to 6 months
Effect of Lactobacillus reuteri on length of hospital stay
Specified length of hospital stay as days.
Measured: up to 6 months
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
NEC diagnosis will make modified Bell's criteria. Grade 1A will not include in NEC group.
Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Apr 2013

First posted10 Feb 2012 (estimated)
Study startJun 2012
Primary completionApr 2013
Study completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Single blind
Who is masked: Participant
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01531192
Sponsor's protocol ID: ZTB630301
Status last verified: Feb 2012
First submitted: 4 Feb 2012
Last updated: 16 Jul 2013
Results posted: No
Data monitoring committee: Yes

Publications

Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9.
PubMed 25245226

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Donor Breast Milk 2
Iron Deficiency Anemia

All Very Low Birth Weight Infants trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Zekai Tahir Burak Maternity Teaching Hospital, Ankara/Turkey
ClinicalTrials.gov ID: NCT01531192
Acronym / sponsor ID: ZTB630301
Conditions: Very Low Birth Weight Infants
Keywords: Lactobacillus reuteri, Nystatin, Very Low Birth Weight Infants, Candida Colonization
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
Study start: Jun 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 10 Feb 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Lactobacillus reuteri	Experimental	Dietary Supplement: Lactobacillus reuteriLactobacillus reuteri 100 million CFU/day for 3 months
Nystatin	Active comparator	Drug: Nystatin50000 unit/3 times a day

Who may qualify

Ages: 1 day to 6 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Very low birth weight infants < 1500 gr
Gestational age < 32 weeks

Key exclusion criteria (4 listed)

Genetic anomalies
Short bowel syndrome
Not willing to participate
Allergy to Lactobacillus reuteri 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
Lactobacillus reuteriAlso: BioGaiaLactobacillus reuteri 100 million CFU/day for 3 months	Dietary supplement	Lactobacillus reuteri
NystatinAlso: Mikostatin50000 unit/3 times a day, both for orally and by orogastric route	Drug	Nystatin

Primary outcome

Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants
Time frame: up to 6 months
Rectal and skin swabs for Candida colonization will be taken weekly. Blood culture for Candida infection will be taken weekly.

4 secondary outcomes

Effect of Lactobacillus reuteri on feeding intolerance
Time frame: up to 6 months
Effect of Lactobacillus reuteri on sepsis
Time frame: up to 6 months
Effect of Lactobacillus reuteri on length of hospital stay
Time frame: up to 6 months
Effect of Lactobacillus reuteri on necrotizing enterocolitis in VLBW infants
Time frame: up to 6 months

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 16 Jul 2013.
Derived from this study: PubMed 25245226Oncel MY, Arayici S, Sari FN, Simsek GK, Yurttutan S, Erdeve O, Saygan S, Uras N, Oguz SS, Dilmen U. Comparison of Lactobacillus reuteri and nystatin prophylaxis on Candida colonization and infection in very low birth weight infants. J Matern Fetal Neonatal Med. 2015;28(15):1790-4. doi: 10.3109/14767058.2014.968842. Epub 2014 Oct 9.
Lactobacillus reuteriLink provided by the sponsor.
NystatinLink provided by the sponsor.

Related trials for Very Low Birth Weight Infants

Recruiting
Effect of Developmental Care on Very Low Birth Weight Infants
Intervention
Active, not recruiting
30% or 60% Oxygen at Birth to Improve Neurodevelopmental Outcomes in Very Low Birthweight Infants
Premature Infant, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 1
Gut Permeability and Microbiome in Preterm Infants
Prematurity Complications
Not yet recruitingObservational study
Predictors of Postnatal Growth Failure in Preterm Infants
Premature Birth, Growth Failure
Recruiting
Donor Breast Milk 2
Iron Deficiency Anemia

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.

Mehmet Yekta Oncel, MD principal investigator

Neonatology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 4 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 16 Jul 2013. 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?

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?

Comparison of prophylactic Lactobacillus reuteri and nystatin on candida colonization and infection in very low birth weight infants (time frame: up to 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 NCT01531192, which also lists 1 linked publication.

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 16 Jul 2013.