Necrotising EnterocolitisPhase 3NCT01899677

The Efficacy of Symbiotic on Cytokines

A Phase 3 study testing distilled water and symbiotic in people with Necrotising Enterocolitis, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 hour to 2 daysHealthy volunteers can take part
Conditions the study is for: Necrotising Enterocolitis
What is being tested?: distilled water and symbiotic
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Jul 2013to Sep 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 hour to 2 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
Neonates who tolerated minimal enteral feeding during first week of life

Who cannot join

PROM> 24 hour and/or chorioamnionitis
Mechanical ventilation supply more than 7 days
Culture proven sepsis
Major congenital anomaly
Neonates undergoing surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Zeynep Kamil Maternity and Child Health Hospital
Istanbul, Umraniye, 34668

Other trials in Turkey (Türkiye)

About this study

Official title: The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants

The aim of this prospective double blinded randomised study is to investigate the efficacy of symbiotic preparation which contains lactobacillus casei, L. rhamnosus, L. plantarum, Bifidobacterium lactis, fructo and galactooligosaccharide on cytokines as interferon-gama acting on Th1 pathway, interleukin -5 acting on Th2, interleukin -10 acting on T regulatory pathway, and interleukin -17 acting on Th-17 pathway that were related with necrotizing enterocolitis pathogenesis in very low birth weight neonates.

Read the detailed description

Inclusion criteria:

Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
Neonates who tolerated minimal enteral feeding within postnatal first week

Exclusion criteria:

PROM> 24 hours and/or chorioamnionitis
Mechanic ventilation supply more than 7 days
Culture proven sepsis
Major congenital anomaly
Patients undergoing surgery

Intervention:

The allocations will contain in opaque, sequentially numbered sealed envelopes. The study group will receive symbiotic preparation (Probiotic ATP, Nobel, 1/2 sachet twice daily); whereas the control group will receive placebo (distilled water; 1 ml per dose twice daily) which will be added to breast milk or formula starting with the first feed.0.5 cc blood sampling will be taken from patients within postnatal 48 hours, 14+2.days, 28+2.days. This samples will turn by cold centrifugation and store at -20 °C temperature. The cytokines will be analysed by ELISA multiplex method.

Conditions: Necrotising Enterocolitis
Being tested: distilled water, symbiotic
Keywords: Symbiotic,cytokines, necrotising enterocolitis
Medical subject headings: Enterocolitis, Necrotizing

What participants receive

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

distilled waterOther
0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
symbioticDrug
Also called Probiotic ATP
Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days

Study groups in NCT01899677
Study group	Role	What they receive
symbiotic	Experimental	symbiotic preparation 1/2 sachet twice daily during 30 days Receives: Drug: symbiotic
distilled water	Placebo comparator	2 x 0.5 cc distilled water will be given during 30 days Receives: Other: distilled water

What is being measured

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

Interleukin 5 Serum Cytokine Level on 0+2 Day
Measured: 0+2 day
Interleukin 5 Levels on 14+/-2 Day
Measured: 14+/-2 day
Interleukin 5 Levels at 28+/-2 Day
Measured: 28+/-2 day
Interleukin 10 Levels at 0+2 Days
Measured: 0+2 days
Interleukin 10 Levels at 14+/- 2 Days
Measured: 14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days
Measured: 28+/-2 days
Interleukin 17A Levels at 0+2 Days
Measured: 0+2 days
Interleukin 17A Levels at 14+/- 2 Days
Measured: 14+/- 2 days
Interleukin 17A Levels at 28+/-2 Days
Measured: 28+/-2 days
Interferon Levels at 0+2 Days
Measured: 0+2 days
Interferon Levels at 14+/-2 Days
Measured: 14+/-2 days
Interferon Levels at 28+/-2 Days
Measured: 28+/-2 days

Timeline

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

Jul 2013Sep 2013

First posted15 Jul 2013 (estimated)
Study startJul 2013
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Necrotising EnterocolitisStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01899677
Sponsor's protocol ID: 14893
Status last verified: Aug 2014
First submitted: 1 Jul 2013
Last updated: 8 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Ng SC, Hart AL, Kamm MA, Stagg AJ, Knight SC. Mechanisms of action of probiotics: recent advances. Inflamm Bowel Dis. 2009 Feb;15(2):300-10. doi: 10.1002/ibd.20602.
PubMed 18626975

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
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

All Necrotising Enterocolitis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Symbiotic Preparation on Cytokines Which Act on Necrotising Enterocolitis Pathogenesis in Very Low Birth Weight Infants
ClinicalTrials.gov ID: NCT01899677
Acronym / sponsor ID: 14893
Conditions: Necrotising Enterocolitis
Keywords: Symbiotic,cytokines, necrotising enterocolitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
Study start: Jul 2013
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 15 Jul 2013 (estimated)
Results: Posted 6 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Inclusion criteria:

Neonates who born 26- 32 gestational week and 750-1500 gram birth weights
Neonates who tolerated minimal enteral feeding within postnatal first week

Exclusion criteria:

PROM> 24 hours and/or chorioamnionitis
Mechanic ventilation supply more than 7 days
Culture proven sepsis
Major congenital anomaly
Patients undergoing surgery

Intervention:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
symbiotic	Experimental	Drug: symbioticsymbiotic preparation 1/2 sachet twice daily during 30 days
distilled water	Placebo comparator	Other: distilled water2 x 0.5 cc distilled water will be given during 30 days

Who may qualify

Ages: 1 hour to 2 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Neonates born 26- 32 gestational weeks and 750-1500 gram birth weights
Neonates who tolerated minimal enteral feeding during first week of life

Key exclusion criteria (5 listed)

PROM> 24 hour and/or chorioamnionitis
Mechanical ventilation supply more than 7 days
Culture proven sepsis
Major congenital anomaly
Neonates undergoing surgery

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
distilled water0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days	Other	distilled water
symbioticAlso: Probiotic ATPSymbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days	Drug	symbiotic

Primary outcome

Interleukin 5 Serum Cytokine Level on 0+2 Day
Time frame: 0+2 day
Interleukin 5 Levels on 14+/-2 Day
Time frame: 14+/-2 day
Interleukin 5 Levels at 28+/-2 Day
Time frame: 28+/-2 day
Interleukin 10 Levels at 0+2 Days
Time frame: 0+2 days
Interleukin 10 Levels at 14+/- 2 Days
Time frame: 14+/- 2 days
Interleukin 10 Levels at 28+/-2 Days
Time frame: 28+/-2 days
Interleukin 17A Levels at 0+2 Days
Time frame: 0+2 days
Interleukin 17A Levels at 14+/- 2 Days
Time frame: 14+/- 2 days
Interleukin 17A Levels at 28+/-2 Days
Time frame: 28+/-2 days
Interferon Levels at 0+2 Days
Time frame: 0+2 days
Interferon Levels at 14+/-2 Days
Time frame: 14+/-2 days
Interferon Levels at 28+/-2 Days
Time frame: 28+/-2 days

Results and safety

Results posted to the registry on 6 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbiotic	35	25
Distilled Water	35	28

Primary outcome: Interleukin 5 Serum Cytokine Level on 0+2 Day

Time frame: 0+2 day. Median (Inter-Quartile Range). Unit: pg/ml

Measure	Symbiotic n = 25	Distilled Water n = 28
Value	4 (2.5 to 5.5)	4 (2 to 4)

Symbiotic vs Distilled Water: p = 0.32, Mann whitney U

Primary outcome: Interleukin 5 Levels on 14+/-2 Day

Time frame: 14+/-2 day. Median (Inter-Quartile Range). Unit: pg/ml

Measure	Symbiotic n = 25	Distilled Water n = 28
Value	4 (2.5 to 7.5)	4 (2.2 to 11.2)

Symbiotic vs Distilled Water: p = 0.73, Mann whitney U

Primary outcome: Interleukin 5 Levels at 28+/-2 Day

Time frame: 28+/-2 day. Mean (Inter-Quartile Range). Unit: pg/ml

Measure	Symbiotic n = 25	Distilled Water n = 28
Value	3 (1 to 4)	3 (2.2 to 4)

Symbiotic vs Distilled Water: p = 0.66, Mann whitney U

Primary outcome: Interleukin 10 Levels at 0+2 Days

Time frame: 0+2 days. Median (Inter-Quartile Range). Unit: pg/ml

Measure	Symbiotic n = 25	Distilled Water n = 28
Value	13 (5.5 to 40.5)	10 (7 to 24)

Symbiotic vs Distilled Water: p = 0.76, Mann whitney U

Adverse events

Time frame: during trial (0-3 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbiotic	0 of 25 (0%)	0 of 25 (0%)	Not reported
Distilled Water	0 of 28 (0%)	0 of 28 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18626975Ng SC, Hart AL, Kamm MA, Stagg AJ, Knight SC. Mechanisms of action of probiotics: recent advances. Inflamm Bowel Dis. 2009 Feb;15(2):300-10. doi: 10.1002/ibd.20602.

Related trials for Necrotising Enterocolitis

Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)

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.

Fahri Ovali study director

Zeynep Kamil Maternity and Childen Education and Training Hospital

Ozge Serce principal investigator

Zeynep Kamil Maternity and Childen Education and Training Hospital

Tugba Gursoy, MD study chair

Zeynep Kamil Maternity and Children Education and Training Hospital

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 5 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 8 Aug 2014. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Interleukin 5 Serum Cytokine Level on 0+2 Day (time frame: 0+2 day). The study lists 12 primary outcomes in all. 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 NCT01899677, 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 8 Aug 2014.