Probiotics Appear Safe and Effective in Treating Children With IBS

October 8, 2008 (Orlando, Florida) — Probiotics might improve quality of life and multiple symptoms in children with irritable bowel syndrome (IBS), according to results from a small new study.

Because few data exist on the safety and effectiveness of IBS treatment in children, a recent study was conducted to look at the effects of the probiotic VSL #3 on 59 patients, aged 4 to 18 years, at 7 pediatric gastroenterology centers in the United States, Italy, and India. The study was presented here at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting and Postgraduate Course by lead investigator Stefano Guandalini, MD, professor of pediatrics at the University of Chicago, in Illinois.

According to his presentation, the study’s primary end point was “improving the subject’s global assessment of relief for children [SGARC], with secondary end points of improving abdominal pain/discomfort, abdominal bloating/gassiness, stool pattern, and the family’s assessment of quality of life.” During the presentation, Dr. Guandalini explained that “the prevalence of school-aged children with IBS can be up to 15%. And even though it’s not life threatening or even health threatening, it’s a real problem for these patients.”

Later, Dr. Guandalini told Medscape Gastroenterology that, “in children, we don’t have a lot of drugs or options of treatment that are as safe as probiotics.” He continued: “Probiotics is a huge area of scientific interest, and this particular combination of VSL #3 has been shown to be useful in other clinical settings. So there are conceptual reasons to expect that they should be beneficial and effective in children as well.”

In this double-blind crossover trial, Dr. Guandalini and his research team assessed 35 male and 24 female patients for 2 weeks by questionnaire before randomly assigning either the probiotic agent (VSL #3, 450 billion lyophilized bacteria/day) or an identical-looking and -tasting placebo for 6 weeks. Children aged 4 to 11 years were treated once a day; children aged 12 to 18 years received doses twice a day. After a 2-week wash-out period, patients were switched to the other group and underwent 6 more weeks of treatment. Parents filled out daily diary questionnaires for children 12 and younger to evaluate their symptoms and overall quality of life before and after each treatment. Patients older than 12 filled out their own questionnaires, with parental supervision. The ratings went from 0 (best) to 5 (worst), and all diaries were collected every 2 weeks.

At the end of the study, Dr. Guandalini’s team found that not only was the probiotic agent safe, it also achieved a statistically significant improvement over placebo in SGARC and alleviated 3 of 4 secondary end points. “There was quite a dramatic slope of improvement there,” said Dr. Guandalini. Although stool pattern showed improvement, it was not deemed statistically significant. There were no prevalent differences between each crossover phase.

SGARC score decreased from 4.0 at baseline to 2.3 after 6 weeks with VLS #3, and from 4.0 at baseline to 3.3 with placebo. Abdominal pain/discomfort decreased from 2.6 to 1.2 after 6 weeks with VLS #3, and from 2.1 to 1.6 with placebo. Abdominal bloating/gassiness decreased from 2.9 to 1.1 after 6 weeks with VLS #3, and from 2.2 to 1.5 with the placebo. For family assessment of quality of life, no patient recorded any adverse effects.

Session moderator Eamonn Quigley, MD, professor of medicine and human physiology at the National University of Ireland, in Cork, and the newly elected president of the ACG, found Dr. Guandalini’s study “very interesting,” although he said a larger study is needed “before we can be convinced [about the results]“. Dr. Quigley told Medscape Gastroenterology that “it’s a small study and it’s got a crossover design, which is slightly problematic in terms of IBS. Obviously I would like to see more data, [such as] a breakdown according to stool type.”

He continued: “Unfortunately, we have a dreadful situation in terms of therapies for adults with IBS. And for children, it’s even worse. [This study] provides more evidence for the efficacy of probiotics. It’s an excellent first step.”

The study did not receive commercial support. Dr. Guandalini disclosed no relevant financial relationships. Dr. Quigley has had research supported by Proctor and Gamble and is affiliated with Alimentary Health, which holds patents in the area of probiotics.

American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting and Postgraduate Course: Abstract 11. Presented October 6, 2008.