The clinical evidence for the 35624® culture comes from two major, gold-standard (placebo-controlled, double-blinded, randomised) clinical trials in IBS patients, headed by internationally renowned gastroenterologists.
“The [35624® culture] is a probiotic for which a beneficial effect for IBS symptoms has been shown in a high-quality, randomized, controlled trial.”Mayer E.A. (2008) Clinical practice. Irritable bowel syndrome. N Engl J Med 358, 1692-9.
Clinical Trial 1:
Efficacy of 35624® in Women with IBS
(Whorwell et al. 2006) 6,8
Objective: To evaluate the efficacy of the 35624® culture at various doses*, for female IBS patients in a primary setting.
Method: This study was a randomised, double-blind, placebo-controlled, multi-centre (20 centres) study. After a two-week baseline assessment period, 362 IBS patients, with any bowel habit subtype, were randomised to receive either placebo or the 35624® strain (in the form of a capsule) at a dose of 1 x 10⁶ or 1 x 10⁸ CFU daily for four weeks. IBS symptoms were monitored daily and scored on a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort. A composite IBS symptom score, the subjects’ global assessment of IBS symptom relief and measures of quality of life (using the IBS-QOL instrument) were also recorded.
Results: Statistically significant improvement associated with the 35624® strain (compared to the placebo) for:
• Abdominal pain/discomfort
• Passage of gas
Significant (20%) increase in global IBS symptom relief for patients taking the 35624® strain, compared to those on placebo.
Conclusion: The 35624® strain at a dosage of 1 x 108 CFU is effective within four weeks in reducing the symptoms of IBS, irrespective of bowel habit subtype.
* Note that a dosage of 1 x 1010 was also tested, but the results were not valid because of technical formulation problems with this dosage (since resolved).
Whorwell P.J. et al. (2006) American Journal of Gastroenterology 101, 1581-90.
Clinical Trial 2:
Efficacy of 35624® in Patients with IBS
(O’Mahony et al. 2005)
Objective: To compare the response of symptoms in IBS to ingestion of probiotic preparations containing either a Lactobacillus or a Bifidobacterium strain.
Method: This was a randomised, double-blind, placebo-controlled study. Subjects with IBS (n=77) were randomised to receive either Lactobacillus salivarius UCC431, the 35624® strain or a placebo for eight weeks. Each strain was given at a dose of 1 x 1010 CFU in a malted milk drink; the malted milk drink alone was the placebo. The cardinal symptoms of IBS were recorded on a daily basis and assessed each week. Quality of life assessment and stool microbiology were performed at the beginning and end of the treatment phase.
Results: Only the 35624® strain improved IBS abdominal pain /discomfort compared to placebo.
Only the 35624® strain improved the IBS composite score¹ compared to placebo.
¹ Sum of abdominal pain/discomfort, bloating/ distension, and bowel movement difficulty scores.
Conclusion: The 35624® strain alleviates symptoms in IBS and manages each of the cardinal symptoms of IBS.23
An educational leaflet for healthcare professionals about the clinical evidence for the 35624® strain can be downloaded here.
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