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BACKGROUND: Probioticbacteria exhibit a variety of properties, including immunomodulatory activity,which are unique to a particular strain. Thus, not all species will necessarilyhave the same therapeutic potential in a particular condition. We havepreliminary evidence that Bifidobacterium infantis 35624 may haveutility in irritable bowel syndrome (IBS).OBJECTIVES: This study wasdesigned to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale,multicenter, clinical trial of women with IBS. A second objective of the studywas to determine the optimal dosage of probiotic for administration in anencapsulated formulation.METHODS: After a 2-wkbaseline, 362 primary care IBS patients, with any bowel habit subtype, wererandomized to either placebo or freeze-dried, encapsulated B. infantisat a dose of 1 × 106, 1 × 108, or 1 × 1010,cfu/mL for 4 wk. IBS symptoms were monitored daily and scored on to a 6-pointLikert scale with the primary outcome variable being abdominal pain ordiscomfort. A composite symptom score, the subject's global assessment of IBSsymptom relief, and measures of quality of life (using the IBS-QOL instrument)were also recorded.RESULTS: B. infantis35624 at a dose of 1 × 108 cfu was significantly superior to placeboand all other bifidobacterium doses for the primary efficacy variable ofabdominal pain as well as the composite score and scores for bloating, boweldysfunction, incomplete evacuation, straining, and the passage of gas at theend of the 4-wk study. The improvement in global symptom assessment exceededplacebo by more than 20% (p < 0.02). Two other doses of probiotic (1× 106 and 1 × 1010) were not significantly different fromplacebo; of these, the 1 × 1010 dose was associated with significantformulation problems. No significant adverse events were recorded.CONCLUSIONS: B. infantis35624 is a probiotic that specifically relieves many of the symptoms of IBS. Ata dosage level of 1 × 108 cfu, it can be delivered by a capsule makingit stable, convenient to administer, and amenable to widespread use. The lackof benefits observed with the other dosage levels of the probiotic highlightthe need for clinical data in the final dosage form and dose of probioticbefore these products should be used in practice.
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