Low Birth WeightPhase 2/3PASNCT01164124
Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
A Phase 2/3 study testing Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) in people with Low Birth Weight, run by Vermont Oxford Network at 3 sites in United States.
Trial summary
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Low Birth Weight
- What is being tested?
- Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2008to Aug 2009
- Phase
- Phase 2/3
- 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 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight less than or equal to 1000 grams,
- appropriately grown for gestational age,
- age 1 to 14 days inclusive,
- intention to start enteral feeds,
- written informed consent obtained
Who cannot join
- known life-threatening congenital anomaly or condition affecting
- gastrointestinal function,
- previous NEC or gastrointestinal perforation,
- previous supplementation with probiotics
- previous enteral feedings
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VT Children's at Fletcher-Allen Health Care
Burlington, Vermont, 05401
St. John Hospital & Medical Center
Detroit, Michigan, 48236
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104-1095
About this study
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.
Read the detailed description
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain. The study also will evaluate the benefit of that feeding supplement in decreasing the rate of infection (in the blood or in the urine) and antibiotics use in those infants.
When babies are born, the digestive system (the gastrointestinal tract) is sterile. There are no bacteria residing in their gut. When babies start feeding, it is normal for the intestine to start growing several types of bacteria. These normal (good) bacteria are thought to be helpful in keeping the intestine healthy. This is not the case in premature infants. It takes premature infants a longer time to grow bacteria in their intestines and they have fewer numbers of bacteria. In addition, the bacteria premature infants grow are not the normal one that we see in healthy infants. Instead they grow unhealthy (bad) bacteria that can potentially play a role in causing infection in the blood and urine.
Adding the normal (good) bacteria to the breast milk or infant formula might help to protect premature babies from developing blood or urine infection. In addition, adding the good bacteria might be beneficial in terms of better tolerance to milk feeding. As a result, babies may have less episodes of feeding holding and have better weight gain. Two species of bacteria, called Lactobacillus and Bifidobacteria, have been used to study this in other studies of premature babies. These two species are the most plentiful bacteria seen in the bowels of full term babies.
Participation in the study involves enrolling premature babies to receive supplement to the feeding when he/she ready to feed. Babies will be randomly assigned to receive either a bacteria (probiotic) supplement or be fed without supplement. The supplement will be added to one feeding each day. Enrolled babies will continue to get the supplement for 6-10 week. Other than the feeding supplement, being in this study will not affect care.
The main outcomes of the study will be feeding tolerance and growth. Other complications associated with prematurity, on particular infection of either the gastrointestinal tract or the blood stream will be evaluated.
- Conditions
- Low Birth Weight
- Being tested
- Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis), Placebo
- Keywords
- extremely low birth weight, probiotics, growth, nutrition, premature infants, growth in extremely low birth weight infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)Dietary supplement
The probiotic regimen consisted of 500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter \& Gamble.Inc)
PlaceboOther
routine feedings
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplementation | Experimental | 500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter \& Gamble.Inc) Receives: Dietary Supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) |
| Routine feedings | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Percentage of infants with weight less than the 10th percentile at 34 weeks postmenstrual age.
Measured: 34 weeks postmenstrual age
Growth
Average weight gain and growth velocity during the first 28 days from initiation of feeding.
Measured: 28 days from study entry
Feeding Tolerance
Volume of feeding per day during the first 28 days from the initiation of feeding.
Measured: 28 days from study entry
Secondary outcomes (2)
Antimicrobial therapy
Days of antimicrobial treatment until 34 weeks post menstrual age.
Measured: 34 weeks post menstrual age
Complications of prematurity
common complications of prematurity including but not limited to sepsis, necrotizing enterocolitis, and mortality.
Measured: until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth WeightStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vermont Oxford Network
- Sponsor type
- Research network
- Collaborators
- University of Vermont, St. Louis University, Cardinal Glennon Children's Hospital, Saint John Hospital & Medical Center
- Responsible party
- Sponsor
- Investigators
- Mohamad Al-Hosni, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164124
- Sponsor's protocol ID
- CHRMS 08-019
- Acronym
- PAS
- Status last verified
- Jun 2018
- First submitted
- 14 Jul 2010
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01164124
- Acronym / sponsor ID
- PAS / CHRMS 08-019
- Conditions
- Low Birth Weight
- Keywords
- extremely low birth weight, probiotics, growth, nutrition, premature infants, growth in extremely low birth weight infants
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Vermont Oxford NetworkResearch network
- Collaborators
- University of Vermont, St. Louis University, Cardinal Glennon Children's Hospital, Saint John Hospital & Medical Center
- Study start
- Feb 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Jul 2010 (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 overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain.
Detailed description
The overall purpose of this research is to test whether adding a supplement to the feeding of extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will help him/her achieve full feeding faster and achieve better weight gain. The study also will evaluate the benefit of that feeding supplement in decreasing the rate of infection (in the blood or in the urine) and antibiotics use in those infants.
When babies are born, the digestive system (the gastrointestinal tract) is sterile. There are no bacteria residing in their gut. When babies start feeding, it is normal for the intestine to start growing several types of bacteria. These normal (good) bacteria are thought to be helpful in keeping the intestine healthy. This is not the case in premature infants. It takes premature infants a longer time to grow bacteria in their intestines and they have fewer numbers of bacteria. In addition, the bacteria premature infants grow are not the normal one that we see in healthy infants. Instead they grow unhealthy (bad) bacteria that can potentially play a role in causing infection in the blood and urine.
Adding the normal (good) bacteria to the breast milk or infant formula might help to protect premature babies from developing blood or urine infection. In addition, adding the good bacteria might be beneficial in terms of better tolerance to milk feeding. As a result, babies may have less episodes of feeding holding and have better weight gain. Two species of bacteria, called Lactobacillus and Bifidobacteria, have been used to study this in other studies of premature babies. These two species are the most plentiful bacteria seen in the bowels of full term babies.
Participation in the study involves enrolling premature babies to receive supplement to the feeding when he/she ready to feed. Babies will be randomly assigned to receive either a bacteria (probiotic) supplement or be fed without supplement. The supplement will be added to one feeding each day. Enrolled babies will continue to get the supplement for 6-10 week. Other than the feeding supplement, being in this study will not affect care.
The main outcomes of the study will be feeding tolerance and growth. Other complications associated with prematurity, on particular infection of either the gastrointestinal tract or the blood stream will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplementation | Experimental | Dietary Supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter \& Gamble.Inc) |
| Routine feedings | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- birth weight less than or equal to 1000 grams,
- appropriately grown for gestational age,
- age 1 to 14 days inclusive,
- intention to start enteral feeds,
- written informed consent obtained
Key exclusion criteria (5 listed)
- known life-threatening congenital anomaly or condition affecting
- gastrointestinal function,
- previous NEC or gastrointestinal perforation,
- previous supplementation with probiotics
- previous enteral feedings
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 supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)The probiotic regimen consisted of 500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter \& Gamble.Inc) | Dietary supplement | Probiotic supplementation |
| Placeboroutine feedings | Other | Routine feedings |
Primary outcome
Growth
Time frame: 34 weeks postmenstrual age
Percentage of infants with weight less than the 10th percentile at 34 weeks postmenstrual age.
Growth
Time frame: 28 days from study entry
Average weight gain and growth velocity during the first 28 days from initiation of feeding.
Feeding Tolerance
Time frame: 28 days from study entry
Volume of feeding per day during the first 28 days from the initiation of feeding.
2 secondary outcomes
Antimicrobial therapy
Time frame: 34 weeks post menstrual age
Complications of prematurity
Time frame: until hospital discharge
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 2 Jul 2018.
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Intervention
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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.
Mohamad Al-Hosni, MD principal investigator
St. Louis University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) in people with Low Birth Weight, run by Vermont Oxford Network at 3 sites in United States.
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 5 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 2 Jul 2018. 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 United States. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Growth (time frame: 34 weeks postmenstrual age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2018.