Microbial ColonizationPhase 3NCT03422562
Probiotics and Intestinal Microbiome in Preterm Infants
A Phase 3 study testing Florababy in people with Microbial Colonization, run by Belal Alshaikh at 1 site in Canada.
Trial summary
The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Read more about this study
- Who is it for?
- Ages 23 to 29 weeks
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Florababy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 26 Oct 2017to 26 Apr 2021
- Phase
- Phase 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 23 to 29 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born less than 29 weeks gestation and <1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary.
Who cannot join
- Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants.
Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and < 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.
- Conditions
- Microbial Colonization
- Being tested
- Florababy
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlorababyDietary supplement
Probiotic supplement
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Florababy probiotic (0.5g per day) will be started at or after 72 hours of life and will be administered in 1ml sterile water prior to feed. Receives: Dietary Supplement: Florababy |
| Control | No intervention | Standard of care arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Microbiome
difference in stool microbiome after Florababy or no drug administration
Measured: 4 weeks
Secondary outcomes (3)
Stool Microbiome
difference in stool microbiome after Florababy or no drug administration
Measured: 2 weeks
Feeding intolerance
Incidence of feeding intolerance
Measured: 4-6 weeks
Full Feeds
Time to reach full feeds.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start26 Oct 2017
- Primary completion30 Mar 2020
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belal Alshaikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Belal Alshaikh, University of Calgary
- Investigators
- Belal Alshaikh, MD, Principal investigator, University of CalgaryBelal Alshaikh, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422562
- Sponsor's protocol ID
- REB16-0542
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alshaikh B, Samara J, Moossavi S, Ferdous T, Soraisham A, Dersch-Mills D, Arrieta MC, Amin H. Multi-strain probiotics for extremely preterm infants: a randomized controlled trial. Pediatr Res. 2022 Dec;92(6):1663-1670. doi: 10.1038/s41390-022-02004-z. Epub 2022 Mar 21.
PubMed 35314794
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
- ClinicalTrials.gov ID
- NCT03422562
- Acronym / sponsor ID
- REB16-0542
- Conditions
- Microbial Colonization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Belal AlshaikhUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 5 Feb 2018 (actual)
- 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 gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants.
Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and < 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: FlorababyFlorababy probiotic (0.5g per day) will be started at or after 72 hours of life and will be administered in 1ml sterile water prior to feed. |
| Control | No intervention | –Standard of care arm |
Who may qualify
- Ages
- 23 to 29 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born less than 29 weeks gestation and <1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary.
Key exclusion criteria (1 listed)
- Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.
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 |
|---|---|---|
| FlorababyProbiotic supplement | Dietary supplement | Probiotic |
Primary outcome
Stool Microbiome
Time frame: 4 weeks
difference in stool microbiome after Florababy or no drug administration
3 secondary outcomes
Stool Microbiome
Time frame: 2 weeks
Feeding intolerance
Time frame: 4-6 weeks
Full Feeds
Time frame: 4-6 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 11 Jan 2022.
- Derived from this study: PubMed 35314794Alshaikh B, Samara J, Moossavi S, Ferdous T, Soraisham A, Dersch-Mills D, Arrieta MC, Amin H. Multi-strain probiotics for extremely preterm infants: a randomized controlled trial. Pediatr Res. 2022 Dec;92(6):1663-1670. doi: 10.1038/s41390-022-02004-z. Epub 2022 Mar 21.
- Individual participant dataSharing planned: Undecided
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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.
Belal Alshaikh, MD principal investigator
University of Calgary
Belal Alshaikh, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Florababy in people with Microbial Colonization, run by Belal Alshaikh at 1 site in Canada.
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 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 11 Jan 2022. 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 Canada. 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. 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?
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?
Stool Microbiome (time frame: 4 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 NCT03422562, 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 11 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.