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Probiotics Supplementation and Length of Hospital Stay 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266315
Recruitment Status : Unknown
Verified August 2017 by Alixe Howlett, University of Calgary.
Recruitment status was:  Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Alixe Howlett, University of Calgary

Brief Summary:
Probiotics have been started in the NICUs in Calgary since 2016 aiming to decrease the incidence of NEC. 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 none-surgical population of infants The main objective of this study is to determine the impact of probiotics administration on length of hospital stay in neonates undergoing intestinal surgery. The study will also generate important data about safety and efficacy of probiotics in this surgical population.

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 : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Probiotics Supplementation and Length of Hospital Stay in Neonates With Gastrointestinal Surgery
Estimated Study Start Date : October 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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. Duration of hospital stay [ Time Frame: 6 weeks ]
    days

  2. Diversity and abundancy of stool microbiome at baseline and after 1 and 3 weeks of initiation of probiotics [ Time Frame: 4 weeks ]
    target bacterial DNA


Secondary Outcome Measures :
  1. Time to reach full feed (defined as 120 ml/kg/day) in the post-operative period [ Time Frame: 4 weeks ]
    days

  2. Incidence of infection as defined by positive bacterial blood, urine or cerebrospinal fluid culture [ Time Frame: 6 weeks ]
    number of episodes

  3. Duration of parenteral nutrition [ Time Frame: 4 weeks ]
    days

  4. Incidence of cholestasis [ Time Frame: 6 weeks ]
    number of episodes

  5. Duration of cholestasis [ Time Frame: 6 weeks ]
    days

  6. Growth anthropometrics Z-scores for weight, head circumference and length [ Time Frame: 6 weeks ]
    Z-score



Information from the National Library of Medicine

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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 - 42 weeks of gestation
  2. Required gastrointestinal surgery (including spontaneous intestinal perforation, necrotizing enterocolitis, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
  3. Ready to start enteral feeding

Exclusion Criteria:

  1. Infants with major congenital anomalies excluding GI tract
  2. Suspected congenital or acquired immune deficiency
  3. Palliative care patient
  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: Veronica M Samedi, MD 403 9441615 Veronica.Samedi@ahs.ca

Locations
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Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Sponsors and Collaborators
University of Calgary
University of Alberta
Investigators
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Principal Investigator: Alixe Howlett, MD University of Calgary
Study Director: Veronica M Samedi, MD University of Calgary
Study Chair: Belal 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: August 30, 2017
Last Verified: August 2017
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
Gastrointestinal Diseases
Digestive System Diseases