Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05734833
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
8 Years
Study:
NCT05734833
Study Brief:
Protocol Section:
NCT05734833