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Abbreviation: N, number of subjects in trial.

Abbreviation: N, number of subjects in trial.

6 gram of VSL#3 or placebo daily for one year or until relapse. Eighty-five percent of the VSL#3 treated group remained in remission at one year compared with 6% (one patient) in the placebo group (Table 4) (97).

Trials in Crohn's Disease

In CD, an early study involved the use of Sacccharomyces boulardii (98). In a doubleblind study, 20 patients with moderately active CD were randomized to treatment with this organism or placebo for 7 weeks. The probiotic treated patients had a significant decrease in CD activity index (CDAI) compared with the control group. More recently, a doubleblind trial randomized 32 CD patients in clinical remission to receive either mesalamine alone or mesalamine plus S. boulardii. Clinical relapse was observed in only 6.25% of patients receiving mesalamine plus S. boulardii, while 37.5% relapse rate was observed in the group receiving mesalamine alone (Table 5) (103).

The efficacy of Lactobacillus rhamnosus GG in the treatment of CD has been studied (99). Malin et al. (99) reported that in pediatric CD, consumption of Lactobacillus GG was associated with increased gut IgA levels which could promote the gut immunological barrier. Gupta et al. (101) also reported improved clinical scores and improved intestinal permeability in an open labeled pilot study in a small study involving four pediatric CD patients.

A double-blind study investigated the use of the E. coli Nissle 1917 strain in CD (100). Malchow et al. randomized 28 patients in remission to receive either E. coli or placebo. At 1-year follow-up, the relapse rates were significantly reduced in the group that received E. coli (30%) compared with 70% in the placebo group. In a large double-blind, randomized study the efficacy of VSL#3 combined with antibiotic treatment on the post-operative recurrence of CD was compared to treatment with mesalamine alone (102). Forty patients

Table 5 Summary of Human Trials of Probiotic Therapy in Crohn's Disease

Study type

Organism used

Trial outcome

Reference

Randomized

Saccharomy-

Decrease in CDAI in probiotic group

Plein et al.

controlled

ces boular-

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