Lacidofil is formulated using Lactobacillus Rosell 52 and Lactobacillus Rosell 11, both of which were selected for their action on the intestinal tract.
It has previously been studied for its effectiveness for antibiotic associated diarrhea and dysbacteriosis, and for reducing lactose intolerance. It is currently available in Canada, some Eastern European countries, and the United States, where it is sold as a food supplement.
Registration is currently underway for some Asian territories and discussions are underway with partners in Western Europe.
The pilot clinical study, published in the journal NUTRAfoods, (v5 (1), pp. 20-27 (2006), was uncontrolled in design. It was conducted at the Thomayer's Teaching Hospital in Prague, Czech Republic and involved 50 patients, all of whom had suffered from chronic IBS for at least ten years.
The patients were given three capsules containing the probiotic formula per day to be taken with meals, equivalent to 6 billion colony forming units per day. They also continued with conventional therapy consisting of antispasmodics, sedatives and calcium.
The effects of adding Lacidofil to conventional therapy, taken in conjunction with a good regimen and diet, were assessed though clinical examination by physicians. They measured changes in the frequency of defecation, stool consistency, abdominal pressure and bloating, flatulence and meteorism, abdominal rumbling and sloshing, abdominal pain and abdominal colic.
At the end of the four-month study period, 88 per cent of participants had an overall reduction of IBS-related complaints.
While this was enough to lead the researchers, led by Dr Z Beneš, to conclude that Lacidofil may be a safe and effective alternative to conventional methods of reducing symptoms, Institut Rosell was also encouraged by the attitude of the participants after the study had come to an end.
"Fourteen patients refused to quit the supplement because of the improvements, while fifteen of them resumed taking it after a relapse in their condition, and this speaks for itself," said Henri Durand, the company's scientific director.
What is more, other patients continued to experience alleviation of complaints after they had stopped taking the probiotic.
Jerome Caussin, probiotic product manager, told NutraIngredients.com that one hypothesis for this is that the probiotic, by diminishing the IBS symptoms during the treatment, helps break IBS vicious circle of stress - permeability - strain - stress... IBS is a long-term condition that usually involves cramping, diarrhea and constipation. It affects an estimated 10 to 20 per cent of the population of western countries.
However the precise cause of IBS is not fully understood and there is no cure yet. Treatments are aimed at alleviating symptoms but medication, for those with moderate to severe forms of the disease, does not work for all patients.
Preliminary science has suggested the potential of probiotic bacteria to protect the gut against the condition, although there are only a handful of probiotic products on the market claiming to target the condition.
The new study builds on data reported from animal studies last year, which measured the sensitivity and function of gut health in rats. Rats that received the probiotic were seen to have a decrease in gut sensitivity and higher protection against increased gut permeability.
The new, human study was relatively long-term for probiotic supplementation but it was still only a pilot. Although they concluded that the results belie potentially beneficial effects on clinical symptoms of IBS, the researchers were aware of the limitations of its design.
"Considering the tendency for a placebo effect in IBS patients, future studies should be placebo-controlled and blinded and designed for long-term follow-up in order to confirm the efficacy of pharmaceutical probiotics in the management of this frequent GIT disorder."
Caussin declined to comment on Institut Rosell's future research plans.