ProbioticsProPSNCT03266315
Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery
A study testing FloraBaby in people with Probiotics and Infant, Newborn, run by University of Calgary at 1 site in Canada.
Trial summary
Congenital defects of the gastrointestinal tract commonly require surgical intervention in the neonatal period. Intestinal surgery during this critical period of microbiome acquisition results in aberrant colonization of the gastrointestinal tract by several pathways. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Probiotics, Infant, Newborn, Surgical Procedures, Operative
- What is being tested?
- FloraBaby
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 3 Dec 2022to 15 Jul 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born between 23 - 41 weeks of gestation
- Required gastrointestinal surgery (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
- Ready to start enteral feeding
Who cannot join
- Infants with major congenital anomalies excluding gastrointestinal tract
- Palliative care patients
- 4. Septic babies with positive blood, CSF or urine culture
Trial locations and contacts
1 site in 1 country.
About this study
Congenital defects of the gastrointestinal tract commonly require surgical intervention in the neonatal period. Intestinal surgery during this critical period of microbiome acquisition results in aberrant colonization of the gastrointestinal tract by several pathways. Surgical stress is known to cause disruption of the gut barrier and increase intestinal permeability and bacterial translocation. This process triggers exaggerated immune responses that lead to inflammation and sometimes infectious complications. Post-operative use of antibiotics has been shown to potentiate the growth of pathogenic bacterial species Adults with abdominal surgery who received post-op probiotics reported a significant reduction in surgical site infection, urinary tract infection, and combined infection. Currently, probiotics used only in the non-surgical population of infants.
The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing intestinal surgery.
Read the detailed description
Research Objectives/Question:
The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing gastrointestinal surgery.
Primary question:
Diversity and abundance of stool microbiome at after 1 and 3 weeks of initiation of probiotics
Secondary outcomes:
- Length of hospital stay
Methodology:
Study design This study will be a randomized controlled double-blinded trial in the NICU at Alberta Children's Hospital. Probiotics or placebo will be administered orally or via naso- or orogastric feeding tube. Intestinal microbiome data will be compared between the two groups. The study duration will be 24 months.
Study Population Infants born between 23 - 41 weeks of gestation, admitted to NICU at Alberta Children's Hospital for gastrointestinal surgery.
- Inclusion Criteria:
- Infants born between 23 - 41 weeks of gestation
- Required gastrointestinal surgery in the first week of life (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
- Ready to start enteral feeding
- Exclusion Criteria:
- Infants with major congenital anomalies excluding gastrointestinal tract 3. Palliative care patients 4. Septic babies with positive blood, CSF or urine culture Sample Size and feasibility: Connivant sample of 20 patients (10 in each group) Study protocol. Infants will be identified within 48 hours of surgery and parents will be approached for informed consent. Once consent is obtained, subjects will be randomly assigned to receive either probiotics or placebo. Investigators will conduct the randomization using a computer-generated table of random numbers generated at the University of Calgary. Preparation and Administration of Study Drug The study supplementation will be started at the when oral feeds will reach 24 mL/kg/day after surgery after collecting a stool/ostomy sample. The decision to start feeding will be made by the neonatal and surgical team. After the first stool/ostomy sample is obtained, one study sachet to a minimum of 1 mL of Expressed Breast Milk (EBM) (mothers own milk or donor human milk) once a day. Placebo sachet will be made of 0.3 g maltodextrin and be administered to the control group in the same manner. If the infant is placed NPO, the study drug will be stopped and restarted together with refeeding. Both probiotics and placebo will be packaged as a single-dose sachet. The study probiotic/placebo will be given till discharge. If the infant is transferred outside NICU, the study drug will be dispensed with the infant and clinical outcomes will be ascertained in collaboration with the local Pediatrician at the time of infants' discharge home. Sample collection Nurses will collect the stool samples at 3-time points: prior to initiation, 1 week after and 3 weeks after probiotic or placebo administration is commenced. "Stool" will be collected directly from the infant's ostomy bag and diaper with a sterile spatula. As soon as a sample is collected, the nurse will contact the investigators. The samples will then be placed in a laboratory freezer (-80°C) within 24 hours of collection. Batched samples will be transported to the University of Calgary Genomics laboratory for subsequent microbiome processing.
- Being tested
- FloraBaby, Placebo
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FloraBabyBiological
Also called Probiotics
1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day
PlaceboOther
1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | subjects will be randomly assigned to receive FloraBaby Receives: Biological: FloraBaby |
| Placebo | Placebo comparator | subjects will be randomly assigned to receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal microbiome
Stool microbiome
Measured: 3 weeks after surgury
Secondary outcomes (1)
Length of hospital stay
Time between birth and hospital discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start3 Dec 2022
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Why it stopped: Manufacturer discontinued the product used for the study: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Belal Alshaikh, University of Calgary
- Investigators
- Alixe Howlett, MD, Principal investigator, University of CalgaryBelal N Alshaikh, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266315
- Sponsor's protocol ID
- REB16-2401
- Acronym
- ProPS
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2017
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT03266315
- Acronym / sponsor ID
- ProPS / REB16-2401
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Manufacturer discontinued the product used for the study: Business decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 30 Aug 2017 (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.
Congenital defects of the gastrointestinal tract commonly require surgical intervention in the neonatal period. Intestinal surgery during this critical period of microbiome acquisition results in aberrant colonization of the gastrointestinal tract by several pathways. Surgical stress is known to cause disruption of the gut barrier and increase intestinal permeability and bacterial translocation. This process triggers exaggerated immune responses that lead to inflammation and sometimes infectious complications. Post-operative use of antibiotics has been shown to potentiate the growth of pathogenic bacterial species Adults with abdominal surgery who received post-op probiotics reported a significant reduction in surgical site infection, urinary tract infection, and combined infection. Currently, probiotics used only in the non-surgical population of infants.
The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing intestinal surgery.
Detailed description
Research Objectives/Question:
The main objective of this study is to determine the impact of probiotics administration on the intestinal microbiome in neonates undergoing gastrointestinal surgery.
Primary question:
Diversity and abundance of stool microbiome at after 1 and 3 weeks of initiation of probiotics
Secondary outcomes:
- Length of hospital stay
Methodology:
Study design This study will be a randomized controlled double-blinded trial in the NICU at Alberta Children's Hospital. Probiotics or placebo will be administered orally or via naso- or orogastric feeding tube. Intestinal microbiome data will be compared between the two groups. The study duration will be 24 months.
Study Population Infants born between 23 - 41 weeks of gestation, admitted to NICU at Alberta Children's Hospital for gastrointestinal surgery.
- Inclusion Criteria:
- Infants born between 23 - 41 weeks of gestation
- Required gastrointestinal surgery in the first week of life (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
- Ready to start enteral feeding
- Exclusion Criteria:
- Infants with major congenital anomalies excluding gastrointestinal tract 3. Palliative care patients 4. Septic babies with positive blood, CSF or urine culture Sample Size and feasibility: Connivant sample of 20 patients (10 in each group) Study protocol. Infants will be identified within 48 hours of surgery and parents will be approached for informed consent. Once consent is obtained, subjects will be randomly assigned to receive either probiotics or placebo. Investigators will conduct the randomization using a computer-generated table of random numbers generated at the University of Calgary. Preparation and Administration of Study Drug The study supplementation will be started at the when oral feeds will reach 24 mL/kg/day after surgery after collecting a stool/ostomy sample. The decision to start feeding will be made by the neonatal and surgical team. After the first stool/ostomy sample is obtained, one study sachet to a minimum of 1 mL of Expressed Breast Milk (EBM) (mothers own milk or donor human milk) once a day. Placebo sachet will be made of 0.3 g maltodextrin and be administered to the control group in the same manner. If the infant is placed NPO, the study drug will be stopped and restarted together with refeeding. Both probiotics and placebo will be packaged as a single-dose sachet. The study probiotic/placebo will be given till discharge. If the infant is transferred outside NICU, the study drug will be dispensed with the infant and clinical outcomes will be ascertained in collaboration with the local Pediatrician at the time of infants' discharge home. Sample collection Nurses will collect the stool samples at 3-time points: prior to initiation, 1 week after and 3 weeks after probiotic or placebo administration is commenced. "Stool" will be collected directly from the infant's ostomy bag and diaper with a sterile spatula. As soon as a sample is collected, the nurse will contact the investigators. The samples will then be placed in a laboratory freezer (-80°C) within 24 hours of collection. Batched samples will be transported to the University of Calgary Genomics laboratory for subsequent microbiome processing.
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 |
|---|---|---|
| Probiotics | Experimental | Biological: FloraBabysubjects will be randomly assigned to receive FloraBaby |
| Placebo | Placebo comparator | Other: Placebosubjects will be randomly assigned to receive placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Infants born between 23 - 41 weeks of gestation
- Required gastrointestinal surgery (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
- Ready to start enteral feeding
Key exclusion criteria (3 listed)
- Infants with major congenital anomalies excluding gastrointestinal tract
- Palliative care patients
- 4. Septic babies with positive blood, CSF or urine culture
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 |
|---|---|---|
| FloraBabyAlso: Probiotics1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day | Biological | Probiotics |
| Placebo1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day | Other | Placebo |
Primary outcome
Intestinal microbiome
Time frame: 3 weeks after surgury
Stool microbiome
1 secondary outcome
Length of hospital stay
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Manufacturer discontinued the product used for the study: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: No
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Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
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Not yet recruiting
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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.
Alixe Howlett, MD principal investigator
University of Calgary
Belal N Alshaikh, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FloraBaby in people with Probiotics and Infant, Newborn, run by University of Calgary 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 3 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: stopped early, as of the sponsor's last update on 18 Jul 2024. 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. 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 (reason given: Manufacturer discontinued the product used for the study: Business decision). 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?
Intestinal microbiome (time frame: 3 weeks after surgury). 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 18 Jul 2024.