Necrotizing EnterocolitisNCT00977912
Necrotizing Enterocolitis (Nec) and B. Lactis in Premature Babies
A study testing Probiotic supplementation in people with Necrotizing Enterocolitis, run by Société des Produits Nestlé (SPN) at 3 sites in South Africa.
Trial summary
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants. Read more about this study
- Who is it for?
- Ages 12 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- Probiotic supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Nov 2009to Sep 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 12 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Weight between 800 - 1500g
- Tolerating enteral feeding within 48 hours
- Having obtained his/her parents or legal representative informed consent
Who cannot join
- Chromosomal abnormality
- Hydrops featalis
- Congenital malformation of the gastrointestinal tract
- Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
- Currently participating in another clinical trial
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
University of Witwatersrand & Chris Hani Baragwanath Hospital
Bertsham, 2013
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
Johannesburg, 2000
University of Witwatersrand & Rahima Moosa Mother & Child Hospital
Johannesburg, 2112
About this study
Official title: Prevention of NEC in Preterm Infants With B. Lactis
The purpose of the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Probiotic supplementation, Milk containing placebo
- Keywords
- B. lactis, Preterm, Necrotizing Enterocolitis (NEC)
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementationDietary supplement
one capsule containing probiotics per day added to milk
Milk containing placeboDietary supplement
one capsule containing placebo per day added to milk
| Study group | Role | What they receive |
|---|---|---|
| "Milk" containing B. Lactis | Experimental | "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. Receives: Dietary Supplement: Probiotic supplementation |
| "Milk" containing placebo | Placebo comparator | "Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. Receives: Dietary Supplement: Milk containing placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEC onset
Measured: 6 weeks
Secondary outcomes (1)
Antibiotic administration and stool microbiology
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionSep 2013
- Study completionSep 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 Necrotizing 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter A. Cooper, MD, Principal investigator, University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977912
- Sponsor's protocol ID
- 08.09.INF
- Status last verified
- Nov 2013
- First submitted
- 15 Sep 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
PubMed 37493095Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
PubMed 33058137
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of NEC in Preterm Infants With B. Lactis
- ClinicalTrials.gov ID
- NCT00977912
- Acronym / sponsor ID
- 08.09.INF
- Conditions
- Necrotizing Enterocolitis
- Keywords
- B. lactis, Preterm, Necrotizing Enterocolitis (NEC)
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 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 the trial is to demonstrate the effect of B. lactis in reducing the incidence of Necrotizing Enterocolitis (NEC) compared to placebo in preterm infants.
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 |
|---|---|---|
| "Milk" containing B. Lactis | Experimental | Dietary Supplement: Probiotic supplementation"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. |
| "Milk" containing placebo | Placebo comparator | Dietary Supplement: Milk containing placebo"Milk" = Breast-milk from the mother, pasteurized breast-milk from a donor, or preterm formula. |
Who may qualify
- Ages
- 12 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Weight between 800 - 1500g
- Tolerating enteral feeding within 48 hours
- Having obtained his/her parents or legal representative informed consent
Key exclusion criteria (5 listed)
- Chromosomal abnormality
- Hydrops featalis
- Congenital malformation of the gastrointestinal tract
- Congenital heart defects or other major congenital abnormalities likely to affect feeding and/or feeding tolerance
- Currently participating in another clinical trial
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 |
|---|---|---|
| Probiotic supplementationone capsule containing probiotics per day added to milk | Dietary supplement | "Milk" containing B. Lactis |
| Milk containing placeboone capsule containing placebo per day added to milk | Dietary supplement | "Milk" containing placebo |
Primary outcome
NEC onset
Time frame: 6 weeks
1 secondary outcome
Antibiotic administration and stool microbiology
Time frame: 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 37493095Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD005496. doi: 10.1002/14651858.CD005496.pub6.
- Derived from this study: PubMed 33058137Sharif S, Meader N, Oddie SJ, Rojas-Reyes MX, McGuire W. Probiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD005496. doi: 10.1002/14651858.CD005496.pub5.
Related trials for Necrotizing Enterocolitis
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The Correlation Between Red Cell Transfusion and Complications of Prematurity
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Necrotizing Enterocolitis, Premature
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.
Peter A. Cooper, MD principal investigator
University of Witwatetersrand & Charlotte Maxek Johannestburg Academic Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic supplementation in people with Necrotizing Enterocolitis, run by Société des Produits Nestlé (SPN) at 3 sites in South Africa.
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 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: stopped early, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. 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 was stopped early. Results are not available in the source record.
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?
NEC onset (time frame: 6 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 NCT00977912, 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 25 Nov 2013.