Phase 4 N=88 Randomized Quadruple-blind Treatment

Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis

Diarrhea

Bottom Line

View on ClinicalTrials.gov: NCT01657032 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Duration of Diarrhea — 2; 2 days — p=0.43

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Smectite (Dietary_supplement); Placebo (Dietary_supplement); Lactobacillus GG (Dietary_supplement)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Medical University of Warsaw
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Diarrhea	2; 2	0.43
SECONDARY Frequency of Loose Stools,	10.5; 10	—
SECONDARY Consistency of Stools	5; 4	—
SECONDARY Need for Antibiotic Therapy,	0; 0	—
SECONDARY Vomiting	0; 0	—
SECONDARY Vomiting	0; 0	—
SECONDARY Diarrhea Recurrence	3; 3	—
SECONDARY Tolerance of Products	34; 32	—
SECONDARY Need for Hospitalization	34; 31	—
SECONDARY Need for Intravenous Therapy	23; 25	—
SECONDARY Duration of Intravenous Therapy	1; 1	—

Summary

Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of both LGG and smectite in management of children with acute gastroenteritis (AGE).

Eligibility Criteria

Inclusion Criteria

children 1 day but 5 days,
a recent history of diarrhea indicated either by parents/guardian or hospital case notes,
underlying chronic gastrointestinal disease,
undernutrition (weight/height ratio below the 5th percentile),
systematic infection,
immune defects or immunosuppressive treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01657032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.