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of the ileal reservoir and is characterized by symptoms, such as rectal bleeding,
increased stool frequency, abdominal cramping, and fever. 62 Gionchetti and col-
leagues 62 investigated the use of VSL#3 as a treatment for active mild pouchitis, as
defined by a pouchitis disease activity index (PDAI) between 7 and 12. In the study,
23 consecutive patients were treated with two sachets twice a day. According to the
PDAI, 3,600 billion bacteria/day for 4 weeks, and symptomatic, endoscopic, and his-
tologic evaluations were taken before and after probiotic treatment. Patient quality
of life was also assessed using the Inflammatory Bowel Disease Questionnaire. Of
the 23 patients, 16 (69 percent) were in remission following probiotic treatment, and
median total PDAI scores, before and after treatment, were 10 and 4, respectively.
The median questionnaire score was also improved, from 110 to 200. Patients deter-
mined to be in remission were placed on a maintenance treatment regimen consisting
of one sachet twice a day (1,800 billion bacteria). None of the 16 patients receiving
the maintenance treatment reported relapse of pouchitis within the experimental
period. 62 VSL#3 has also been investigated by Bibiloni and colleagues, in the setting
of active UC. 13 In this study, 34 patients with active UC were treated with two sachets
twice a day (3,600 billion bacteria/day) for a period of 6 weeks. Using the ulcerative
colitis disease activity index (UCDAI) as a guide, patients were determined to be
in either remission (UCDAI ≤ 2); response (decrease in UCDAI ≤ 3 points, but final
score ≥ 3); no response or worsening (increase in UCDAI). Of the 32 patients who
completed the trial, 18 (53 percent) were determined to be in remission, while 8 (24
percent) reported a positive response to treatment. No response was reported in 3 (9
percent) patients, and another three (9 percent) reported a worsening of UC.
Positive results have also been observed for UC treatment using the BIO-THREE
tablet formulation. 20 Tsuda and colleagues investigated this probiotic combination,
which comprised Streptococcus faecalis T-110, Clostridium butyricum TO-A, and
Bacillus mesentericus TO-A in 20 patients with mild to moderate distal UC. Patients
ingested 9 tablets daily for a period of 4 weeks, with UCDAI scores obtained prior
to and following treatment. By using a system similar to that described by Bibiloni et
al., 13 treatment was determined to elicit remission, response, no response, or worsen-
ing. Remission was observed in 9 (45 percent) patients, response in 2 (10 percent), no
response in 8 (40 percent), and worsening in only 1 (5 percent). Fecal samples were
also obtained from patients, with the microbiota analyzed via the terminal-restric-
tion fragment length polymorphism (T-RFLP) method. An increase in bifidobacteria
was the principal alteration to the intestinal microflora following probiotic treatment.
This was particularly interesting, as no bifidobacteria were administered within the
probiotic supplement. The reason for this increase remains unknown, but could
represent a consequence of the treatment altering the environment to facilitate the
growth of bifidobacteria, perhaps by removal of competing pathogens.
Administration of E. coli Nissle 1917 has been reported to both induce and
maintain remission of UC in numerous studies. 63-65 In a randomized, double-blind
clinical trial of patients in remission from UC, treatment with Nissle 1917 led to
relapse rates statistically similar to patients receiving the antibiotic mesalazine. 63
These findings were confirmed in a larger, double-blind, double-dummy trial, dur-
ing which relapse rates of UC patients receiving Nissle 1917 or melasalazine were
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