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Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery (ProPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266315
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : March 15, 2021
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Alixe Howlett, University of Calgary

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Probiotics Infant, Newborn Surgical Procedures, Operative Gastro-Intestinal Disorder Biological: FloraBaby Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Probiotics Supplementation and Intestinal Microbiome in Neonates With Gastrointestinal Surgery
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Arm Intervention/treatment
Experimental: Probiotics
subjects will be randomly assigned to receive FloraBaby
Biological: FloraBaby
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
Other Name: Probiotics

Placebo Comparator: Placebo
subjects will be randomly assigned to receive placebo
Other: Placebo
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




Primary Outcome Measures :
  1. Intestinal microbiome [ Time Frame: 3 weeks after surgury ]
    Stool microbiome


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 6 months ]
    Time between birth and hospital discharge



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants born between 23 - 41 weeks of gestation
  2. Required gastrointestinal surgery (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
  3. Ready to start enteral feeding

Exclusion Criteria:

  1. Infants with major congenital anomalies excluding gastrointestinal tract
  2. Palliative care patients

4. Septic babies with positive blood, CSF or urine culture


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266315


Contacts
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Contact: Alixe Howlett, MD 4039557442 alixe.howlett@ahs.ca
Contact: Belal N Alshaikh, MD 403 956 1588 balshaik@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Contact: Belal M ALshaikh, MD    4039561588    balshaik@ucalgary.ca   
Contact: Alixe M Howlett, MD       alixe.howlett@ahs.ca   
Principal Investigator: Belal M Alshaikh, MD         
Sponsors and Collaborators
University of Calgary
University of Alberta
Investigators
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Principal Investigator: Alixe N Howlett, MD University of Calgary
Study Chair: Belal N AlShaikh, MD University of Calgary
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Responsible Party: Alixe Howlett, Clinical Associate Professor, Department of Pediatrics, University of Calgary
ClinicalTrials.gov Identifier: NCT03266315    
Other Study ID Numbers: REB16-2401
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases