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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Lactobacillus Reuteri DSM 17938 for the Treatment of Acute Gastroenteritis in Children

NCT02989350

Acute Gastroenteritis

COMPLETED NA

Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

NCT01968408

Diarrhea

COMPLETED PHASE3

LGG for Prevention of Infectious Complications During PPI Treatment in Children

NCT01782118

Gastroesophageal Reflux Disease Gastrointestinal Infections Respiratory Tract Infections

UNKNOWN PHASE4

Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children

NCT04836013

Diarrhea Caused by Drug Abdominal Pain

UNKNOWN NA

Efficacy of an Oral Rehydration Solution Containing the Probiotic Lactobacillus Reuteri Protectis and Zinc in Infants With Acute Gastroenteritis

NCT01886755

Acute Gastroenteritis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to be beneficial in meta-analyses. Treatment with LGG was associated with a significant reduction in diarrhea duration.

A recent review systematically evaluated the efficacy of smectite in treating acute infections diarrhea in infants and children.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactobacillus GG and Smectite

Children received:

* LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and
* smectite, dose 3 g, once daily orally until diarrhea stopped

Group Type EXPERIMENTAL