Preterm InfantsBifido(RCT)NCT01375309
Bifidobacterium Supplementation for Very Low Birth Weight Infants
A study testing Bifidobacterium bifidum supplementation in people with Preterm Infants, run by Tokyo Women's Medical University at 1 site in Japan.
Trial summary
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Preterm Infants
- What is being tested?
- Bifidobacterium bifidum supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2010to Dec 2011
- 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 Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with birth weight less than 1500g
Who cannot join
- Sever bacteremia
- Congenital anomaly
- Not suitable for the trial defined by an attending neonatologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.
- Conditions
- Preterm Infants
- Being tested
- Bifidobacterium bifidum supplementation, Placebo contains dextrin
- Keywords
- probiotics, preterm infants, enteral feeding, Bifidobacterium on enteral feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium bifidum supplementationDietary supplement
Also called Bifidobacterium bifidum OLB6378
Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day
Placebo contains dextrinDietary supplement
0.5 of dextrin
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Bifidobacterium bifidum Receives: Dietary Supplement: Bifidobacterium bifidum supplementation |
| Placebo | Placebo comparator | Dextrin without Bifidobacterium bifidum Receives: Dietary Supplement: Placebo contains dextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal day when enteral feeding exceeded at 100ml/kg/day
Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.
Measured: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth
Secondary outcomes (3)
standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)
BW gain/day, SD scores of BW and HC at discharge from NICU
Measured: For the duration of NICU stay, an expected average of 3 months
Necrotizing enterocolitis or sepsis
The incidences of necrtizing enterocolitis or sepsis during the stay in NICU
Measured: For the duration of NICU stay, an expected average of 3 months
Intestinal flora
Intestinal flora during the stay in NICU
Measured: For the duration of NICU stay, an expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionJun 2011
- Study completionDec 2011
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 Preterm 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokyo Women's Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Satoshi Kusuda, Tokyo Women's Medical University
- Investigators
- Satoshi Kusuda, MD, Principal investigator, Tokyo Women's Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375309
- Sponsor's protocol ID
- 1675
- Other IDs
- UMIN000002543
- Acronym
- Bifido(RCT)
- Status last verified
- Mar 2012
- First submitted
- 6 Jun 2011
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bifidobacterium Bifidum Supplementation on Morbidity of Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01375309
- Acronym / sponsor ID
- Bifido(RCT) / 1675
- Conditions
- Preterm Infants
- Keywords
- probiotics, preterm infants, enteral feeding, Bifidobacterium on enteral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Tokyo Women's Medical UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Jun 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.
Probiotic supplementation to preterm infants have been reported to be beneficial in neonatal intensive care unit (NICU). Our pilot study also showed accelerated feeding in preterm infants who received Bifidobacterium bifidum early after birth. In order to evaluate these beneficial effects of Bifidobacterium bifidum, a prospective randomized control study is conducted. The hypothesis of the study is that Bifidobacterium bifidum supplementation to preterm infants improve enteral feeding and growth in very low birth weight infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Bifidobacterium bifidum supplementationBifidobacterium bifidum |
| Placebo | Placebo comparator | Dietary Supplement: Placebo contains dextrinDextrin without Bifidobacterium bifidum |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with birth weight less than 1500g
Key exclusion criteria (3 listed)
- Sever bacteremia
- Congenital anomaly
- Not suitable for the trial defined by an attending neonatologist
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 bifidum supplementationAlso: Bifidobacterium bifidum OLB6378Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day | Dietary supplement | Active |
| Placebo contains dextrin0.5 of dextrin | Dietary supplement | Placebo |
Primary outcome
Postnatal day when enteral feeding exceeded at 100ml/kg/day
Time frame: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth
Death or unsuccessful of establishing enteral feeding exceeded at 100ml/kg/day before day 28 of age is considered failure to reach primary endpoint.
3 secondary outcomes
standard deviation(SD) scores of bodyweight(BW) and head circumference(HC)
Time frame: For the duration of NICU stay, an expected average of 3 months
Necrotizing enterocolitis or sepsis
Time frame: For the duration of NICU stay, an expected average of 3 months
Intestinal flora
Time frame: For the duration of NICU stay, an expected average of 3 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 30 Mar 2012.
- 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 Preterm Infants
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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
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
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Satoshi Kusuda, MD principal investigator
Tokyo Women's Medical University
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 bifidum supplementation in people with Preterm Infants, run by Tokyo Women's Medical University at 1 site in Japan.
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: finished, as of the sponsor's last update on 30 Mar 2012. 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 Japan. 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?
Postnatal day when enteral feeding exceeded at 100ml/kg/day (time frame: From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth). 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 NCT01375309, 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 30 Mar 2012.