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Do Probiotics Improve Recovery From Acute Constipation in Kids?

Primary Purpose

Constipation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturelle Probiotic + Fiber
Placebo
Sponsored by
Connecticut Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

6 Months - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who present to ED with acute constipation. Children whose primary reason for the ED visit or primary discharge diagnosis is acute constipation, as determined by the treating attending physician or advanced practitioner AND with fewer than 3 spontaneous stools within 1 week and overall symptoms lasting less than 2 months. Age 6 months to 8 years (9th birthday) Ability to communicate effectively in English or Spanish A working email for follow-up. Exclusion Criteria: Patients with behavioral issues, developmental delays, or autism. Patients with the following chronic medical conditions: Inflammatory Bowel Disease, Cystic Fibrosis, Cancer, Hypothyroidism, or Hyperthyroidism. Patients with chronic or functional constipation (>2 months) Patients with any known gastrointestinal disease (such as Crohn's, ulcerative colitis, etc.) Patients who have presented to the ED for acute constipation multiple times (as documented by chart) Patients with an eating disorder Patients who have taken a probiotic within the last 7 days Patients who take a probiotic or antibiotic at any point throughout the duration of the study Previous participation in the study Admitted to the hospital

Sites / Locations

  • Connecticut Chidlren's Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Participants in this study arm will be receiving a 28-day supply of probiotic.

Participants in this study arm will be receiving a 28-day supply of placebo.

Outcomes

Primary Outcome Measures

Time to normal frequency of stool after onset of constipation
Mean days with constipation assessed using the Bristol stool score

Secondary Outcome Measures

Improvement in abdominal pain
Mean days with abdominal pain reported

Full Information

First Posted
February 9, 2023
Last Updated
February 9, 2023
Sponsor
Connecticut Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05734833
Brief Title
Do Probiotics Improve Recovery From Acute Constipation in Kids?
Official Title
Do Probiotics Improve Recovery From Acute Constipation in Kids?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
September 22, 2025 (Anticipated)
Study Completion Date
September 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Connecticut Children's Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, we believe it is prudent to evaluate for added benefit first. Specifically, we 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive the Probiotic and the other group will receive the placebo.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Children will be randomly placed into either the probiotic group or no probiotic group in a 1:1 ratio. A 28-day supply of either probiotic or placebo will be given to each subject. Neither the research assistant nor the subject will be told which group they are in. All providers and research staff will be blinded, with the exception of Dr. Sharon Smith (Co-PI). The method for randomizing, labeling and packaging for home will be reviewed with the CT Children's pharmacy and we will follow their standard practices. The CT Children's pharmacy has been approached and agrees that for probiotics the pharmacy does not need to be directly involved
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Participants in this study arm will be receiving a 28-day supply of probiotic.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this study arm will be receiving a 28-day supply of placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Culturelle Probiotic + Fiber
Intervention Description
The experimental group will receive the study product which is Culturelle Probiotic + Fiber
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The Placebo comparator arm will receive placebo sachets
Primary Outcome Measure Information:
Title
Time to normal frequency of stool after onset of constipation
Description
Mean days with constipation assessed using the Bristol stool score
Time Frame
1-28 days of study period
Secondary Outcome Measure Information:
Title
Improvement in abdominal pain
Description
Mean days with abdominal pain reported
Time Frame
1-28 days of study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who present to ED with acute constipation. Children whose primary reason for the ED visit or primary discharge diagnosis is acute constipation, as determined by the treating attending physician or advanced practitioner AND with fewer than 3 spontaneous stools within 1 week and overall symptoms lasting less than 2 months. Age 6 months to 8 years (9th birthday) Ability to communicate effectively in English or Spanish A working email for follow-up. Exclusion Criteria: Patients with behavioral issues, developmental delays, or autism. Patients with the following chronic medical conditions: Inflammatory Bowel Disease, Cystic Fibrosis, Cancer, Hypothyroidism, or Hyperthyroidism. Patients with chronic or functional constipation (>2 months) Patients with any known gastrointestinal disease (such as Crohn's, ulcerative colitis, etc.) Patients who have presented to the ED for acute constipation multiple times (as documented by chart) Patients with an eating disorder Patients who have taken a probiotic within the last 7 days Patients who take a probiotic or antibiotic at any point throughout the duration of the study Previous participation in the study Admitted to the hospital
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susana D Collazo, MD
Phone
8564691140
Email
scollazo@connecticutchildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Smith, MD
Email
srsmith@connecticutchildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susana D Collazo, MD
Organizational Affiliation
Connecticut Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Chidlren's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana D Collazo, MD
Phone
856-469-1140
Email
scollazo@connecticutchildrens.org
First Name & Middle Initial & Last Name & Degree
Sharon Smith, MD
Phone
8605459295
Email
srsmith@connecticutchildrens.org
First Name & Middle Initial & Last Name & Degree
Susana D Collazo, MD
First Name & Middle Initial & Last Name & Degree
Sharon Smith, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Do Probiotics Improve Recovery From Acute Constipation in Kids?

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