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Probiotic

Probiotics for Post-Surgery Newborns with Gastrointestinal Disorders (ProPS Trial)

N/A
Recruiting
Led By Alixe N Howlett, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Required gastrointestinal surgery (including spontaneous intestinal perforation, bowel atresia, mechanical bowel obstruction, volvulus, gastroschisis)
Infants born between 23 - 41 weeks of gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

ProPS Trial Summary

This trial will test whether giving neonates probiotics following intestinal surgery will reduce the number of infections they experience.

Who is the study for?
This trial is for newborns born between 23-41 weeks of gestation who need gastrointestinal surgery and are ready to start enteral feeding. It excludes infants with major congenital anomalies not related to the gut, those with confirmed infections (blood, CSF, or urine), or babies receiving palliative care.Check my eligibility
What is being tested?
The study tests the effects of a probiotic called FloraBaby on neonates' intestinal microbiome after they've had gastrointestinal surgery. The goal is to see if these supplements can improve gut health post-surgery compared to a placebo.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, common side effects of probiotics in general may include digestive discomfort such as gas or bloating. In very rare cases, people with underlying health conditions could experience more serious complications.

ProPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had surgery on my digestive system.
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My baby was born between 23 and 41 weeks of pregnancy.
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I am prepared to begin tube feeding.

ProPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intestinal microbiome
Secondary outcome measures
Length of hospital stay

ProPS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticsExperimental Treatment1 Intervention
subjects will be randomly assigned to receive FloraBaby
Group II: PlaceboPlacebo Group1 Intervention
subjects will be randomly assigned to receive placebo

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
783 Previous Clinical Trials
845,918 Total Patients Enrolled
1 Trials studying Gastrointestinal Disorder
337 Patients Enrolled for Gastrointestinal Disorder
Alixe N Howlett, MDPrincipal InvestigatorUniversity of Calgary
Belal N AlShaikh, MDStudy ChairUniversity of Calgary

Media Library

FloraBaby (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03266315 — N/A
Gastrointestinal Disorder Research Study Groups: Probiotics, Placebo
Gastrointestinal Disorder Clinical Trial 2023: FloraBaby Highlights & Side Effects. Trial Name: NCT03266315 — N/A
FloraBaby (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03266315 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities still available for this clinical investigation?

"Affirmative, the clinicaltrials.gov registry displays that this research endeavour is actively seeking participants. It was first publicized on December 3rd 2022 and underwent its most recent edit on November 4th of that same year. At present, 20 people are needed to be enrolled at one medical site."

Answered by AI

How many test subjects are actively engaged in this investigation?

"That is correct. According to the information posted on clinicaltrials.gov, this medical trial has opened its recruitment window and is currently seeking 20 patients from a single site. The initial posting of the study was made on December 3rd 2022, with an update being applied as recently as November 4th 2022."

Answered by AI
~9 spots leftby Mar 2025