Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care … (NCT06109740) | Clinical Trial Compass
CompletedNot Applicable
Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
21 participantsStarted 2008-10
Plain-language summary
The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question\[s\] it aims to answer are:
* Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU
* Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics
If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.
Who can participate
Age range
1 Day – 17 Years
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:
* Admitted to PICU
* Requiring \> 72 hrs of antibiotic therapy
* \< 17 years
* Able to administer oral LGG or placebo
Exclusion Criteria:
* Antibiotics 48 hours prior to hospital admission
* Probiotic use within 7 days of admission
* Pre-existing diarrhea at time of hospital admission or 24 hours prior to admission
* Laxative therapy at time of admission or 48 hours prior to admission
* HIV with CD4 \< 250
* Established immunologic deficiencies (ANC \< 100)
* Chronic steroid therapy ( \> 10 days)
* GI disorders including intussusception, lower bowel disease, bowel resection, irritable bowel syndrome, ulcerative colitis, or Crohn's disease
* Status post-surgical patients with antibiotic prophylaxis (\< 72 hours duration)
* NPO
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
1
Incidence of antibiotic associated diarrhea
Timeframe: Full time while on antibiotics and 48 hours after