Clinical trial NCT05734833: Do Probiotics Improve Recovery From Acute Constipation in Kids?
Official title: Do Probiotics Improve Recovery From Acute Constipation in Kids?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Constipation
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive the Probiotic and the other group will receive the placebo.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to normal frequency of stool after onset of constipation
timeFrame: 1-28 days of study period
Secondary outcomes:
measure: Improvement in abdominal pain
timeFrame: 1-28 days of study period
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Chidlren's Medical Center
state: Connecticut
Study officials:
affiliation: Connecticut Children's Medical Center
name: Susana D Collazo, MD
role: PRINCIPAL_INVESTIGATOR
References: