Major Finding: Overall, 75% of patients randomized to Lactobacillus GG returned to normal stool, vs. 70% of those receiving placebo.

Data Source: Double-blind randomized trial of Lactobacillus GG in 129 children with acute infectious diarrhea.

Disclosures: Amerifit Brands Inc. provided the study product and placebo, and a small patient incentive. Dr. Nixon disclosed no conflicts of interest.

VANCOUVER — Contrary to prior studies, Lactobacillus GG did not significantly affect the overall duration or severity of acute infectious diarrhea in a double-blind, randomized trial of 129 children presenting in the pediatric emergency department.

Children with longer diarrheal illness however, appeared to respond better to outpatient use of Lactobacillus GG (LGG), said Dr. Abigail Nixon, a pediatric fellow in training at the Jacobi Medical Center, Bronx, N.Y., at the annual meeting of the Pediatric Academic Societies.

Probiotics have been shown to decrease the duration of infectious diarrhea, although there are no U.S. studies of the use of probiotics to treat infectious diarrhea in the outpatient setting.

The study involved 129 children, aged 6 months to 6 years (mean 25.5 months), presenting to the emergency department (ED) with acute diarrhea, defined as more than two loose stools in the preceding 24 hours (mean 5.3 episodes). Patients were randomized to 10 capsules of dissolvable powder containing LGG or placebo containing inulin, a polysaccharide.

Parents administered the powder twice daily for 5 days and recorded in a home diary the number of stools. A blinded researcher called the caregiver daily for 5 days, and recorded the number of stools and the date and time of the first normal stool.

The percentage of children returning to normal stool during the study period was similar among patients randomized to LGG and those receiving placebo, at 75% and 70%, respectively, Dr. Nixon said.

There also was no significant difference in the median time to normal stool—60 hours with LGG vs. 74 hours with placebo—or in the number of diarrheal stools during the study—5.0 with LGG vs. 6.5 with placebo.

The lack of a significant benefit from LGG may be caused by the fact that children treated and discharged from the ED are in general not as ill as those who are admitted, Dr. Nixon explained, and therefore it's more difficult to document an effect of the probiotic.

“I think there's a population of children who probably have very mild disease who don't benefit from probiotics because they don't need it; they would have gotten better on their own,” she said in an interview. “I think that's why as a group as a whole, we didn't see a meaningful difference.”

Still, the results support a trend for a benefit of probiotics, she added.

Among patients presenting with more than 2 days of diarrhea, a post hoc subgroup analysis revealed that a significantly higher percentage of the LGG patients returned to normal stool than did placebo-treated patients, 79% vs. 58%, respectively.

In addition, LGG patients returned to normal stool almost 24 hours earlier than did their counterparts treated with placebo (51 hours vs. 74 hours), and had half the number of diarrheal stools (3.5 vs. 7). Both differences were statistically significant.

After the researchers adjusted for age, children with more than 2 days of diarrhea treated with LGG were twice as likely to return to normal stool as were children in the placebo group.

“LGG may have a restorative effect on the intestinal flora and therefore would preferentially benefit patients presenting with prolonged diarrhea,” said Dr. Nixon, who recommends probiotics, either as tablets or fortified yogurt, to her patients in the ED.

She noted that a reduction in the time to resolution of diarrhea might have important public health implications in terms of missed work, lost revenue, and school absenteeism.

Diarrhea accounts for about 1.5 million pediatric outpatient visits and more than 200,000 hospitalizations annually in the United States, Dr. Nixon said at the meeting.

An analysis of the study's secondary outcomes among the entire cohort found no difference between groups in the time for patient or parents to return to normal activity or in the need to return for medical care or hospitalization.

Session moderator Dr. Benard P. Dreyer, professor of pediatrics at New York University, wondered whether LGG might have been less effective because of the increasing rate of rotavirus vaccination in children. Dr. Nixon said the impact of rotavirus is unclear, as viral cultures were not conducted.

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The population that has very mild disease doesn't benefit from probiotics because they don't need it.

Source DR. NIXON

Probiotic May Benefit Children With Prolonged Diarrhea