CompletedPhase 2

Probiotic Prophylaxis of Hirschprung's Disease Associated Enterocolitis (HAEC)

United States62 participantsStarted 2006-09

Plain-language summary

Prospective, randomized, controlled trial to test if post-operative administration of probiotics in HD patients will lead to a reduction in the occurrence of HAEC.

Who can participate

Age range

1 Month – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients eligible for enrollment will include all pediatric patients suffering from HD at an age of 12 months or younger. All patients will require consent by either parent or adult guardian Exclusion Criteria: * Patients will be excluded if children that are deemed hemodynamically unstable and require immediate operative intervention, age more than one year of age, as this may mean very delay in diagnosis and may affect the study results, or infants having major congenital anomalies with short life expectancy. Additional exclusion criteria are those patients' parents or adult guardian who refuse to undergo randomization. Finally, those children who are transferred to another non-participating hospital will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Patients Diagnosed With Hirschsprung-associated Enterocolitis (HAEC).

Timeframe: 6 months post-pullthrough

Severity of Clinical Episodes of HAEC

Timeframe: 6 months

Trial details

NCT IDNCT00630838

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-09

Results submitted2015-04-01

View on ClinicalTrials.gov More Hirschsprung Disease trials

Who can participate

Age range

1 Month – 12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.