Clinical Use

It is generally agreed that a probiotic must be capable of colonising the intestinal tract to influence human health. Currently, one of the most extensively studied probiotics is Lactobacillus GG. Probiotic supplements are usually standardised in terms of the amount of living organisms per unit of volume and dosages range from 1 billion colonies to as high as 450 billion daily. DIARRHOEA

Infectious diarrhoea A Cochrane review analysed results from 23 RCTs that compared a specified probiotic agent with placebo or no probiotic in people with acute diarrhoea proven or presumed to be caused by an infectious agent (Allen et al 2004). Overall, 1917 volunteers were involved, of whom 1449 were infants or children (age <18 years). The review concluded that probiotics reduced the risk of diarrhoea at 3 days and the mean duration of diarrhoea by 30.5 hours and supplementation was a useful adjunct to rehydration therapy in treating acute, infectious diarrhoea in adults and children. Several different probiotics were tested: all were lactic acid bacilli, except in two studies that tested the yeast Saccharomyces boulardii. With the exception of a trial of live Streptococcus thermophilus and Lactobacillus bulgaricus, a beneficial effect in the probiotic group compared to controls was observed in all trials. Due to the variation in treatment regimens, further investigation is required to clarify which particular one is best in specific patient groups.

Travellers' diarrhoea Travellers' diarrhoea Is the most common health problem In those visiting developing countries, affecting 20% to more than 50% of tourists. Although it is usually benign, travellers' diarrhoea represents a considerable socioeconomic burden for both the traveller and the host country. The most common enteropathogen is Escherichia coli.

Some clinical studies have found various probiotics somewhat effective against travellers' diarrhoea; however no probiotic has been able to demonstrate clinically relevant protection worldwide (Rendi-Wagner & Kollaritsch 2002).

A large, randomised, placebo-controlled double-blind study of the efficacy of Lactobacillus GG in preventing travellers' diarrhoea involved 820 people on holiday to Turkey to two destinations. The group was randomly assigned either L GG or placebo in identical sachets. On the return flight each participant completed a questionnaire indicating the incidence of diarrhoea and related symptoms during the trip. Of the original group, 756 (92%) subjects completed the study. The overall incidence of diarrhoea was 43.8% (331 cases) and the total incidence of diarrhoea in the L GG group was 41.0% compared with 46.5% in the placebo group, indicating an overall protection of 11.8%. Protection rates varied between two different destinations, with the maximum protection rate reported as 39.5% and no side-effects reported (Oksanen et al 1990).

In another placebo-controlled double-blind study, two doses (250 mg and 1000 mg) of Saccharomyces boulardii were administered prophylactically to 3000 Austrian travellers. A significant reduction in the incidence of diarrhoea was observed, with success depending directly on the rigorous use of the preparation. A tendency was noted for 5. boulardii to have a regional effect, which was particularly marked in North Africa and in Turkey. The effect was dose-dependent, with participants taking the higher dose of probiotics experiencing the lowest incidence of travellers' diarrhoea (29%) and little difference observed between low-dose 5. boulardii supplementation (34%) and placebo (39%). Treatment was considered very safe (Kollaritsch et al 1993).

AIDS-related diarrhoea Two studies have found probiotics beneficial in the treatment of AIDS-related diarrhoea. In patients given 5. boulardii (3 g/day of the yeast) for 1 week, 10 of 18 improved compared with 1 of 11 patients given placebo. In another study, a similar protocol improved the condition of 7 of 11 patients (Elmer 2001).

Antibiotic-induced diarrhoea According to a 2002 meta-analysis, Lactobacillus spp. and Saccharomyces boulardii are superior to placebo in preventing antibiotic- Probiotics 949

associated diarrhoea. Of nine randomised, double-blind placebo-controlled trials of

probiotics, two of which involved children, four used the yeast 5. boulardii, four used lactobacilli, one used a strain of Enferococcus-producing lactic acid, and three used a combination of probiotics.

In all nine trials, probiotics were given in combination with antibiotics, whereas the control groups received placebo with the antibiotic treatment. The odds ratio in favour of active treatment over placebo in preventing diarrhoea associated with antibiotics was 0.39 for 5. boulardii and 0.34 for lactobacilli (D'Souza et al 2002). Clostridium difficile-associated diarrhoea (CDAD) Clostridium difficile is a common cause of diarrhoea associated with treatment with antimicrobial and/or antibiotic medication and can potentially progress to colitis, pseudomembranous colitis, toxic megacolon and death. In spite of antimicrobial therapy, recurrence is common. The 5. boulardii strain of bacteria is being used to restore microbial balance and inhibit C. difficile proliferation (Elmer 2001) and has been used as an adjunct to vancomycin treatment.

A 2005 systematic review of RCTs conducted to assess the effectiveness of probiotic therapy in the prevention or treatment of C. difficile-associated diarrhoea (CDAD) reported that the benefit of probiotic therapy was seen in two studies and restricted to subgroups characterised by severe CDAD and increased use of vancomycin (Dendukuri et al 2005). Due to the heterogeneity in choice and dose of probiotic and in the criteria for diagnosing CDAD, synthesising further information from the eight studies was difficult, leaving the authors to conclude that better designed and larger studies are required.

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