Objectives To catalog what is known about the safety of interventions containing Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus strains used as probiotic agents in research to reduce the risk of, prevent, or treat disease. Data sources We searched 12 electronic databases, references of included studies, and pertinent reviews for studies addressing the safety of probiotics from database inception to August 2010 without language restriction. Review methods We identified intervention studies on probiotics that reported the presence or absence of adverse health outcomes in human participants, without restriction by study design, participant type, or clinical field. We investigated the quantity, quality, and nature of adverse events. Results The search identified 11,977 publications, of which 622 studies were included in the review. In 235 studies, only nonspecific safety statements were made ("well tolerated"); the remaining 387 studies reported the presence or absence of specific adverse events. Interventions and adverse events were poorly documented. A number of case studies described fungemia and some bacteremia potentially associated with administered probiotic organisms. Controlled trials did not monitor routinely for such infections and primarily reported on gastrointestinal adverse events. Based on reported adverse events, randomized controlled trials (RCTs) showed no statistically significantly increased relative risk (RR) of the overall number of experienced adverse events (RR 1.00; 95% confidence interval [CI]: 0.93, 1.07, p=0.999); gastrointestinal; infections; or other adverse events, including serious adverse events (RR 1.06; 95% CI: 0.97, 1.16; p=0.201), associated with short-term probiotic use compared to control group participants; long-term effects are largely unknown. Existing studies primarily examined Lactobacillus alone or in combination with other genera, often Bifidobacterium. Few studies directly compared the safety among different intervention or participant characteristics. Indirect comparisons indicated that effects of delivery vehicles (e.g., yogurt, dairy) should be investigated further. Case studies suggested that participants with compromised health are most likely to experience adverse events associated with probiotics. However, RCTs in medium-risk and critically ill participants did not report a statistically significantly increased risk of adverse events compared to control group participants. Conclusions There is a lack of assessment and systematic reporting of adverse events in probiotic intervention studies, and interventions are poorly documented. The available evidence in RCTs does not indicate an increased risk; however, rare adverse events are difficult to assess, and despite the substantial number of publications, the current literature is not well equipped to answer questions on the safety of probiotic interventions with confidence.

Safety of probiotics used to reduce risk and prevent or treat disease.

OBJECTIVE: Experimental and clinical studies have shown that a novel symbiotic (known as SCM-III) exerts a beneficial effect on gut translocation and local and systemic inflammatory and microbial metabolic parameters. The present investigation was a preliminary trial on the effectiveness of SCM-III for irritable bowel syndrome (IBS).

METHODS:  Sixty-eight consecutive adult patients with IBS who were free from lactose malabsorption, abdominal surgery, overt psychiatric disorders and ongoing psychotropic drug therapy or ethanol abuse were studied prospectively and divided into 2 groups that were comparable for age, gender, body size, education and pattern of presenting symptoms. The 2 groups were blindly given for 12 weeks either SCM-III 10 mL t.i.d or the same dosage of heat-inactivated symbiotic.

RESULTS:  Treatment with SCM-III was ‘effective’ or ‘very effective’ in more than 80% of the patients (P < 0.01 vs baseline values and control). Less than 5% reported ‘not effective’ as the final evaluation compared with over 40% of patients in the control group. After 6 weeks of treatment, a significant improvement of pain and bloating was reported in the treatment group compared with control and baseline values. There was also a benefit for bowel habits, mostly for patients with constipation or alternating bowel habits. No overt clinical or biochemical adverse side-effects were recorded.

CONCLUSION:  Compared with baseline values and the control group, SCM-III resulted in a significant increase in lactobacilla, eubacteria and bifidobacteria, which suggests that some selected IBS patients could benefit substantially from symbiotics, but the treatment may need to be given on a cyclic schedule because of the temporary modification of the fecal flora.

Single-blind follow-up study on the effectiveness of a symbiotic preparation in irritable bowel syndrome.

Aim To investigate the effectiveness and safety of a symbiotic mixture in preventing recurrence of constipation-related abdominal pain in patients with uncomplicated diverticular disease of the colon Methods Forty-six consecutive patients (10 men, 36 women, mean age 625 years, range 49 to 77 years), previously affected by symptomatic uncomplicated diverticular disease of the colon, were enrolled in a 6-month follow-up study in a prospective, randomized, open-label study The following symptoms were assessed at entry and through follow-up by using a quantitative scale: constipation, diarrhoea and abdominal pain After recruitment, the patients were assigned to the following treatment: SCM-III symbiotic mixture, 10 ml three times a day The colonization of ingested Lactobacillus acidophilus 145 and Bifidobacterium spp 420 was assessed by species-specific PCR Forty-five patients completed the study (97%) Results Thirty-one patients (68%) were still symptom free after the 6th month of treatment Treatment with SCM-III was regarded as "effective" or "very effective" in more than 78% of the patients altogether (p Conclusions The present symbiotic mixture seems to be effective in preventing recurrence of symptomatic uncomplicated diverticular disease of the colon, especially in those patients with constipation-predominant features

/pdf/probiotics-in-diverticular-disease-of-the-colon-an-open-49go2rgsl0.pdf

Probiotics in diverticular disease of the colon: an open label study.

The present invention provides a method for the treatment and/or prophylaxis of inflammatory bowel disease (IBD) comprising administering a therapeutically effective amount of an inhibitor of CSF-1 activity.

Use of an inhibitor of csf-1 activity for the treatment of inflammatory bowel disease

Objectives: To ascertain the role of antibiotics in induction and maintenance of remission in ulcerative colitis (UC)Methods: We searched electronic databases for keywords ulcerative colitis or inf...

Antibiotics for induction and maintenance of remission in ulcerative colitis: systematic review and meta-analysis

OBJECTIVES:  The aims of the present study were to investigate the plasma concentration of endotoxin in patients with inflammatory bowel disease (IBD), the effect of metronidazole (MNZ) and of symbiotics on that concentration, and the relationship to IBD activity.



METHODS:  The study group comprised 26 patients with quiescent ulcerative colitis (UC), all of whom were on maintenance mesalazine treatment (1200− 2400 mg/day). The control group comprised 15 subjects. Blood samples were taken from all study subjects to measure: routine blood chemistry, endotoxin concentration, lipopolysaccharide binding protein (LBP) and macrophage-colony stimulating factor (M-CSF). All the IBD patients were randomly enrolled for a 2-week oral daily treatment regimen with either MNZ (250 mg t.i.d.) or the symbiotic mixture SCM-III (Lactobacillus acidophilus, L. helveticus and Bifidobacteria brevis in an ion- and vitamin-enriched medium; 3 mL t.i.d.). Following a 6-week washout period during which the patients continued their maintenance treatment, the cross-over study of the new treatments was begun. Blood parameters were checked at entry and 2 weeks after each treatment schedule.



RESULTS:  The concentration of endotoxin level in the UC patients, as a whole, was comparable with that of the control subjects. However, a separate group of patients with long-standing disease and pancolitis showed a statistically significant increase in toxin. SCM-III, but not MNZ, normalized this parameter. There was no statistical change in LBP and plasma endotoxin-inhibiting capacity in the IBD patients. The M-CSF concentration was increased in the UC group, particularly in the pancolitis subgroup. SCM-III, but not MNZ, significantly decreased the M-CSF concentration in the UC patients, but there was only an insignificant trend toward decrease in the subgroup. There was a significant correlation between M-CSF and endotoxin in the pancolitis subgroup (r: 0.74, P < 0.05).



CONCLUSIONS:  Although these preliminary results need to be treated with caution, they suggest the effectiveness of long-term administration of probiotics/symbiotics in conjunction with standard treatment in patients with UC, even if there is not gross disease activity.

Disrupted mucosal barrier in quiescent ulcerative colitis: effect of metronidazole and of a symbiotic preparation in a pilot cross-over study

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Disrupted mucosal barrier in quiescent ulcerative colitis: effect of metronidazole and of a symbiotic preparation in a pilot cross-over study