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Do Probiotics Improve Recovery From Acute Constipation in Kids?

NCT05734833 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-07-14

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Culturelle Probiotic + Fiber

The experimental group will receive the study product which is Culturelle Probiotic + Fiber

OTHER

Placebo

The Placebo comparator arm will receive placebo sachets

Sponsors & Collaborators

  • Connecticut Children's Medical Center

    lead OTHER

Principal Investigators

  • Susana D Collazo, MD · Connecticut Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2025-02-18
Completion
2025-02-18

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734833 on ClinicalTrials.gov