Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-09 @ 3:41 PM
Study NCT ID:
NCT05734833
Status:
WITHDRAWN
Last Update Posted:
2025-07-14
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Do Probiotics Improve Recovery From Acute Constipation in Kids?
Sponsor:
Connecticut Children's Medical Center
Organization:
Study Overview
Official Title:
Do Probiotics Improve Recovery From Acute Constipation in Kids?
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the potential benefit of adding probiotics to the standard treatment for children who present to the emergency department with acute constipation. Before evaluating probiotics as a single therapy, the investigators believe it is prudent to evaluate for added benefit first. Specifically, they seek to determine if adding probiotics decreases the length of time to normal stool frequency, decreases the number of days with abdominal pain/cramping, and improves time to normal eating/drinking.
Detailed Description:
Research Assistants will screen for eligible subjects using the ED electronic tracking board in Care Navigator. Initially, subjects will be identified by chief complaint and age. The Research Assistant will follow up with the care provider to determine whether the subject meets any of the exclusion criteria. If the subject does not meet any of the exclusion criteria, the medical provider will obtain permission from the subject and subject's family for the Research Assistant to enter the room.
After permission to approach the family is obtained from the attending physician or other pertinent caregiver, the PI/investigator, or trained RA (URAP student) will enter the patient's room, explain the study and obtain informed consent.
A survey on will be administered. This will be on a password protected smart device (iPad, or tablet) via RedCap data platform and to be completed by a parent or guardian. The survey will ask about certain criteria for inclusion to ensure the subject is eligible for enrollment in the study. The survey will also ask questions about symptoms the patient may be experiencing.
The samples will be stored in a secure, locked cabinet located in the medical supply/medication storage area of the Emergency Department. It will be accessible by medical staff including the charge nurse or attending on each shift. Each study packet has a study ID number on it and contains either placebo or probiotic. The survey completed by parent on tablet will have a randomly assigned study ID. The staff will provide the subject with the correlating study packet. RedCap will store the packet number so unblinding may occur for the interim and final analyses.
The parent or guardian of patients in both groups will be given directions to access the daily online journal in which to record their child's ingestion of the probiotic and bowel activity for 28 days.
Study staff will ask for demographic information for the parent and child: age, race and ethnicity, sex, phone number, and email (for follow-up, explained later). This information will be tracked in a password protected excel file.
Recruitment will occur over 3 years with a goal of 300 participants. The Culturelle product that we are using in the study comes in sachets. Each sachet has 2.5 billion CFU's per sachet. The dosing is 1 sachet 3 times a day.
After permission to approach the family is obtained from the attending physician or other pertinent caregiver, the PI/investigator, or trained RA (URAP student) will enter the patient's room, explain the study and obtain informed consent.
A survey on will be administered. This will be on a password protected smart device (iPad, or tablet) via RedCap data platform and to be completed by a parent or guardian. The survey will ask about certain criteria for inclusion to ensure the subject is eligible for enrollment in the study. The survey will also ask questions about symptoms the patient may be experiencing.
The samples will be stored in a secure, locked cabinet located in the medical supply/medication storage area of the Emergency Department. It will be accessible by medical staff including the charge nurse or attending on each shift. Each study packet has a study ID number on it and contains either placebo or probiotic. The survey completed by parent on tablet will have a randomly assigned study ID. The staff will provide the subject with the correlating study packet. RedCap will store the packet number so unblinding may occur for the interim and final analyses.
The parent or guardian of patients in both groups will be given directions to access the daily online journal in which to record their child's ingestion of the probiotic and bowel activity for 28 days.
Study staff will ask for demographic information for the parent and child: age, race and ethnicity, sex, phone number, and email (for follow-up, explained later). This information will be tracked in a password protected excel file.
Recruitment will occur over 3 years with a goal of 300 participants. The Culturelle product that we are using in the study comes in sachets. Each sachet has 2.5 billion CFU's per sachet. The dosing is 1 sachet 3 times a day.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: