Gastroenteritis
Conditions
Keywords
Lactobacillus rhamnosus GG, LGG, Probiotic, Gastroenteritis, acute gastroenteritis, child, pediatric, RCT
Brief summary
The investigators will study the efficacy and side effect profile of LGG, a probiotic, in pediatric patients with acute gastroenteritis.
Detailed description
Multicenter randomized controlled trial of LGG in patients 3-48 months of age presenting to the Emergency Department with acute gastroenteritis.
Interventions
DRUGLGG
LGG 10\^10 cfu PO BID X 5 days
1 capsule PO bid x 5 days
Sponsors
Columbia University
Northwestern University
University of New Mexico
Children's National Research Institute
University of Utah
Wayne State University
Children's Hospital Medical Center, Cincinnati
University of Michigan
Brown University
University of California, Davis
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 48 Months
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Modified Vesikari Scale Score >=9 | 14 days | This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With LGG Bacteremia | 1 month | bacteremia caused by LGG |
| Diarrhea Duration | 14 days | diarrhea duration in hours after randomization |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus Rhamnosus GG LGG 10\^10 cfu PO bid x 5 days
LGG: LGG 10\^10 cfu PO BID X 5 days | 483 |
| Placebo micro-crystalline cellulose PO bid x 5 days
micro-crystalline cellulose: 1 capsule PO bid x 5 days | 488 |
| Total | 971 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 13 |
Baseline characteristics
| Characteristic | Lactobacillus Rhamnosus GG | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 1.4 years | 1.4 years | 1.4 years |
| Median Modified Vesikari Scale score at presentation | 12 units on a scale | 12 units on a scale | 12 units on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 176 Participants | 162 Participants | 338 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 16 Participants | 40 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 121 Participants | 138 Participants | 259 Participants |
| Race (NIH/OMB) White | 144 Participants | 163 Participants | 307 Participants |
| Region of Enrollment United States | 483 participants | 488 participants | 971 participants |
| Sex: Female, Male Female | 236 Participants | 222 Participants | 458 Participants |
| Sex: Female, Male Male | 247 Participants | 266 Participants | 513 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 483 | 0 / 488 |
| other Total, other adverse events | 55 / 483 | 49 / 488 |
| serious Total, serious adverse events | 8 / 483 | 13 / 488 |
Outcome results
Primary
Number of Participants With Modified Vesikari Scale Score >=9
This is a validated gastroenteritis severity score that includes duration and frequency of diarrhea, duration and frequency of vomiting, duration and frequency of fever and use of health care resources. Scores \>=9 indicate moderate-severe gastroenteritis. Higher is worse.
Time frame: 14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactobacillus Rhamnosus GG | Number of Participants With Modified Vesikari Scale Score >=9 | 55 Participants |
| Placebo | Number of Participants With Modified Vesikari Scale Score >=9 | 60 Participants |
p-value: 0.83Mantel Haenszel
Secondary
Diarrhea Duration
diarrhea duration in hours after randomization
Time frame: 14 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lactobacillus Rhamnosus GG | Diarrhea Duration | 49.7 hours |
| Placebo | Diarrhea Duration | 50.9 hours |
p-value: 0.26Van Elteren's modification Mann-Whitney
Secondary
Number of Participants With LGG Bacteremia
bacteremia caused by LGG
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactobacillus Rhamnosus GG | Number of Participants With LGG Bacteremia | 0 Participants |
| Placebo | Number of Participants With LGG Bacteremia | 0 Participants |