Congenital Heart DiseaseNCT01810978
Synbiotics in Infants With Cyanotic Congenital Heart Disease
A study testing Bifidobacterium lactis plus inulin and Maltodextrin in people with Congenital Heart Disease, run by Dr. Sami Ulus Children's Hospital at 1 site in Turkey (Türkiye).
Trial summary
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD Read more about this study
- Who is it for?
- Ages 1 day to 3 months
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Bifidobacterium lactis plus inulin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2012to May 2013
- 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 day to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cyanotic congenital heart disease
- infants >35 weeks of gestational age
- Born at or transferred to Sami Ulus CH
Who cannot join
- Congenital anomalies of the intestinal tract
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Read the detailed description
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
- Conditions
- Congenital Heart Disease
- Being tested
- Bifidobacterium lactis plus inulin, Maltodextrin
- Keywords
- congenital heart disease, probiotic, prebiotic
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium lactis plus inulinDietary supplement
5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
MaltodextrinDietary supplement
same amount of maltodextrin per day will be given as placebo
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium lactis plus inulin | Active comparator | Bifidobacterium lactis plus inulin Receives: Dietary Supplement: Maltodextrin |
| maltodextrin | Placebo comparator | maltodextrin Receives: Dietary Supplement: Bifidobacterium lactis plus inulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis
Measured: 8 weeks
Secondary outcomes (1)
Necrotizing enterocolitis
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionMay 2013
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 Congenital Heart DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sami Ulus Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Dilli, Dr. Sami Ulus Children's Hospital
- Investigators
- Banu Aydın, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810978
- Sponsor's protocol ID
- 128/01.10.2012
- Status last verified
- May 2013
- First submitted
- 12 Mar 2013
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellis CL, Rutledge JC, Underwood MA. Intestinal microbiota and blue baby syndrome: probiotic therapy for term neonates with cyanotic congenital heart disease. Gut Microbes. 2010 Nov-Dec;1(6):359-66. doi: 10.4161/gmic.1.6.14077.
PubMed 21468216Dilli D, Aydin B, Zenciroglu A, Ozyazici E, Beken S, Okumus N. Treatment outcomes of infants with cyanotic congenital heart disease treated with synbiotics. Pediatrics. 2013 Oct;132(4):e932-8. doi: 10.1542/peds.2013-1262. Epub 2013 Sep 16.
PubMed 24043284
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Synbiotics in Infants With Cyanotic Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT01810978
- Acronym / sponsor ID
- 128/01.10.2012
- Conditions
- Congenital Heart Disease
- Keywords
- congenital heart disease, probiotic, prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Sami Ulus Children's HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Mar 2013 (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.
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. The investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Detailed description
Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. Probiotics may prevent pathogen colonization in infants with CHD. Therefore, the investigators hypothesized that synbiotics may reduce the rate of sepsis and necrotizing enterocolitis in infants with CHD
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium lactis plus inulin | Active comparator | Dietary Supplement: MaltodextrinBifidobacterium lactis plus inulin |
| maltodextrin | Placebo comparator | Dietary Supplement: Bifidobacterium lactis plus inulinmaltodextrin |
Who may qualify
- Ages
- 1 day to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cyanotic congenital heart disease
- infants >35 weeks of gestational age
- Born at or transferred to Sami Ulus CH
Key exclusion criteria (1 listed)
- Congenital anomalies of the intestinal tract
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 |
|---|---|---|
| Bifidobacterium lactis plus inulin5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given | Dietary supplement | maltodextrin |
| Maltodextrinsame amount of maltodextrin per day will be given as placebo | Dietary supplement | Bifidobacterium lactis plus inulin |
Primary outcome
Sepsis
Time frame: 8 weeks
1 secondary outcome
Necrotizing enterocolitis
Time frame: 8 weeks
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 9 May 2013.
- Results publication: PubMed 21468216Ellis CL, Rutledge JC, Underwood MA. Intestinal microbiota and blue baby syndrome: probiotic therapy for term neonates with cyanotic congenital heart disease. Gut Microbes. 2010 Nov-Dec;1(6):359-66. doi: 10.4161/gmic.1.6.14077.
- Derived from this study: PubMed 24043284Dilli D, Aydin B, Zenciroglu A, Ozyazici E, Beken S, Okumus N. Treatment outcomes of infants with cyanotic congenital heart disease treated with synbiotics. Pediatrics. 2013 Oct;132(4):e932-8. doi: 10.1542/peds.2013-1262. Epub 2013 Sep 16.
- http://www.ncbi.nlm.nih.gov/pubmed/21468216Link provided by the sponsor.
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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.
Banu Aydın, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium lactis plus inulin and Maltodextrin in people with Congenital Heart Disease, run by Dr. Sami Ulus Children's 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 3 inclusion and 1 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 9 May 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. 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?
Sepsis (time frame: 8 weeks). 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 NCT01810978, 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 9 May 2013.