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

See Contacts and Locations

Sponsor:

Collaborator:

University of Alberta

Information provided by (Responsible Party):

Alixe Howlett, University of Calgary

Study Description

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

Show detailed description

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:

1. 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:
1. Infants born between 23 - 41 weeks of gestation
2. Required gastrointestinal surgery in the first week of life (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 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

Layout table for study information

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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Intestinal microbiome [ Time Frame: 3 weeks after surgury ]
Stool microbiome

Secondary Outcome Measures :

Length of hospital stay [ Time Frame: 6 months ]
Time between birth and hospital discharge

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Infants with major congenital anomalies excluding gastrointestinal tract
Palliative care patients

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

Contacts and Locations

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

Layout table for location contacts

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

Locations

Layout table for location information

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

Layout table for investigator information

Principal Investigator:	Alixe N Howlett, MD	University of Calgary
Study Chair:	Belal N AlShaikh, MD	University of Calgary

More Information

Layout table for additonal information

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

Layout table for additional information

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

Layout table for MeSH terms

Intestinal Diseases Digestive System Diseases Gastrointestinal Diseases

To Top