Constipation Clinical Trial
Official title:
Do Probiotics Improve Recovery From Acute Constipation in Kids?
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 22, 2025 |
Est. primary completion date | September 22, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Months to 8 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Connecticut Chidlren's Medical Center | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Connecticut Children's Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to normal frequency of stool after onset of constipation | Mean days with constipation assessed using the Bristol stool score | 1-28 days of study period | |
Secondary | Improvement in abdominal pain | Mean days with abdominal pain reported | 1-28 days of study period |
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