Do Probiotics Improve Recovery From Acute Constipation in Kids?

NCT05734833 | Withdrawn

• 1 other identifier: 18-136
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement in abdominal pain

  1-28 days of study period

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Dietary Supplement: Culturelle Probiotic + Fiber

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Culturelle Probiotic + Fiber DIETARY_SUPPLEMENT

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

Probiotic

Placebo OTHER

The Placebo comparator arm will receive placebo sachets

Placebo

Eligibility Criteria

• Age: 6 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Chidlren's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Constipation

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Susana D Collazo, MD

  Connecticut Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive the Probiotic and the other group will receive the placebo.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: March 24, 2022
• Primary Completion: February 18, 2025
• Study Completion: February 18, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)