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Placebo-Controlled Trial Shows Which IBS Patients Respond to Probiotic Treatment: Presented at ACG
By Paula Moyer
HONOLULU, HI -- November 3, 2005 -- Patients with irritable bowel syndrome (IBS) who have symptoms of hard stool or urgency are the most likely to respond to the probiotic agent Bifidobacterium infantis 35624 (Bifantis), according to research presented here at the 70th annual meeting of the American College of Gastroenterology (ACG).
Probiotics are bacterial strains. Patients with IBS often buy probiotics as supplements over-the-counter, said principal investigator Eamonn M. M. Quigley, MD, Professor of Medicine and Human Physiology, Alimentary Pharmabiotic Center of National University of Ireland, Cork, Ireland.
"There is an increasing demand for well-designed trials regarding probiotic agents," he said during his presentation on November 1st. "Whether you look at animal models or tissue culture models, there is an emerging amount of data regarding probiotics, so there is now a basis in science."
In the current research, Dr. Quigley and his co-investigators conducted a double-blind, placebo-controlled trial of B. infantis 35624 in IBS patients. They then analyzed the patients' baseline characteristics to see whether any specific symptoms predicted whether patients would respond to treatment.
Of the 173 patients, 87 were in the treatment group and 86 were in the placebo group. At the end of the 4-week treatment phase, 55 patients in the treatment group (63.2%) and 40 patients in the placebo group responded to treatment (46.5%).
Among responders, those with hard stool were nearly three times as likely to respond to treatment, with an odds ratio of 2.84. Those with urgency were 1.45 times as likely to respond as other patients.
Dr. Quigley said that patients who had symptoms of straining were less likely to respond, with an odds ratio of 0.33.
When the investigators adjusted for baseline predictors, those in the treatment group were 2.15 times as likely to respond as those in the placebo group.
The study was funded by Procter & Gamble, which manufactures Bifantis. Dr. Quigley is a consultant and shareholder in the company.
[Presentation title: Who is the Responder to Probiotic Therapy in IBS? Data from a Controlled Clinical Trial with Bifidobacterium Infantis 35624. Abstract 827]
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