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Probiotics for Childhood Constipation

N/A

Recruiting

Led By Susana D Collazo, MD

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-28 days of study period

Awards & highlights

Study Summary

This trial will study if probiotics can help children with constipation feel better sooner, with fewer days of pain and quicker return to normal eating/drinking.

Who is the study for?

This trial is for children aged 6 months to 8 years who are experiencing acute constipation and have had fewer than three bowel movements in the past week. They must be able to communicate in English or Spanish, have a working email, and not have chronic medical conditions like IBD or thyroid disorders.Check my eligibility

What is being tested?

The study tests if adding Culturelle Probiotic + Fiber to standard treatment helps kids recover faster from acute constipation compared to a placebo. It measures time to normal stool frequency, days with abdominal pain, and return to normal eating/drinking.See study design

What are the potential side effects?

While probiotics are generally considered safe, potential side effects may include mild digestive symptoms such as gas or bloating. However, specific side effects related to this trial's intervention will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-28 days of study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-28 days of study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-28 days of study period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to normal frequency of stool after onset of constipation

Secondary outcome measures

Improvement in abdominal pain

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProbioticExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Connecticut Children's Medical CenterLead Sponsor

71 Previous Clinical Trials

31,214 Total Patients Enrolled

Susana D Collazo, MDPrincipal InvestigatorConnecticut Children's Medical Center

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05734833 — N/A

Constipation Research Study Groups: Probiotic, Placebo

Constipation Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05734833 — N/A

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05734833 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is the ideal participant for this clinical trial?

"To qualify for the trial, candidates must be suffering from constipation and lie between 6 months to 8 years old. The total recruitment target is 300 participants."

Answered by AI

Are people below the age of seventy permissible to join this experiment?

"The parameters to join this trial include being between 6 months old and 8. There are 25 spots available for minors while 54 spots are allocated to those over the age of 65."

Answered by AI

Are there remaining spots available for this research study?

"According to the information furnished on clinicaltrials.gov, this research initiative is still recruiting suitable candidates and was first posted on September 22nd 2022 with its last update occuring earlier in February 9th 2023."

Answered by AI

How many volunteers have signed up for this medical experiment?

"Affirmative, the clinicaltrials.gov website states that this investigation is actively enrolling patients at this time. Originally posted on September 22nd 2022 and last updated February 9th 2023, 300 participants need to be recruited from one trial site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Do Probiotics Improve Recovery From Acute Constipation in Kids?

2022. "Do Probiotics Improve Recovery From Acute Constipation in Kids?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05734833.

All > Constipation