Impact of Emergency Department Probiotic (LGG) Treatment of Pediatric Gastroenteritis

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Data is not saved in preview.
"Can probiotics help children with stomach flu?"
Age:
3 months to 4 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Stomach flu, gastroenteritis
Type:
Drug study, Phase 2/3
Investigator:
Description
The purpose of this research study is to improve the care of children who are suffering from intestinal infections by using a probiotic. Probiotics are bacteria present in nutritional supplements and foods such as yogurt that are believed to be safe and good for people. Early research suggests that probiotics may help children with intestinal infections. In this study we will look at the use of a probiotic called LGG compared to a placebo (sometimes referred to as a “sugar pill”) in children with intestinal infections. This study will help us know whether probiotics may help these children.
LGG is considered investigational, which means that it has not been approved by the U.S. Food and Drug Administration to be used as a medication. However the FDA has given us permission to use LGG as part of this study
This study requires
History and physical form completed by child's pediatrician
Stool sample
Probiotic/Placebo administration
Surveys completed on-line or phone call
Complete diary provided
Who can participate?
Inclusion Criteria:

1. Age 3-48 months (have not yet reached their fourth birthday); AND

2. Presence of 3 or more watery stools within 24 hours of screening; AND

3. Duration of vomiting or diarrhea less than 7 days; AND

4. Symptoms consistent with acute intestinal infectious process.


Exclusion Criteria:

1. Presence of an indwelling vascular access line; OR

2. Presence of structural heart disease excluding non-pathological heart murmurs; OR

3. Receiving immunosuppressive therapy or history of immunodeficiency; OR

4. Hematochezia in the preceding 48 hours; OR

5. Chronic gastrointestinal problems (e.g. short gut syndrome, inflammatory bowel disease); OR

6. Patients with known pancreatitis; OR

7. History of abdominal surgery; OR

8. Critically ill patients; OR

9. Family member with an indwelling vascular access line, or on immunosuppressive therapy, or with a known immunodeficiency; OR

10. Bilious emesis; OR

11. Probiotic use (supplement) in the preceding 2 weeks; OR

12. Oral or intravenous steroid use in the preceding six months; OR

13. Previously enrolled in this trial; OR

14. Allergy to lactobacillus or Microcrystalline Cellulose (MCC); OR

15. Allergy to erythromycin, clindamycin, AND betalactam antibiotics (all); OR

16. Not available for daily follow-up while symptomatic; OR

17. Parent/guardian not speaking English or Spanish; OR

18. Under 6 months old AND premature (<37 weeks).
Compensation
• $10 per telephone call/electronic survey completed on days 1, 2, 3, 4, 5, and 14. A check or gift card will be mailed to you after the day 14 follow-up contact (allow 2 weeks for processing and shipping).
• $8 per telephone call/electronic survey completed on months 1, 3, 6, 9, and 12. A check or gift card(s) will be mailed to you after the month 12 follow-up contact (allow 2 weeks for processing and shipping). If you choose the gift card option, you will receive one card for each completed follow-up contact at months 1, 3, 6, 9, and 12. If you choose the check option, you will receive a lump sum payment for the number of follow-up contacts completed at month 12.
• If you withdraw from the study, you will only be paid for completed follow-up contacts
Resources
Schedule
Study duration and period
12 months
Recruitment period
From March 19, 2014
Location
UC Davis Children's Hospital
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Michelle Nguyen
Research Topic
Conditions:
  • Gastroenteritis

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


Sending

Send SMS with Study Info:

SMS Sent!

Share Study Info via Email:


E-mail Preview