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PROBIOTICS (VSL3) IN ARTHRALGIA. PRELIMINARY
RESULTS OF AN ONGOING OPEN TRIAL IN PATIENTS WITH
ULCERATIVE COLITIS AND CROHN DISEASE Ouafae
Karimi, Amado Salvador Peña, Adriaan A. van
Bodegraven Depts. Gastroenterology and Laboratory
of Immunogenetics, VUMC, Amsterdam, The
Netherlands
I n t r o d u c t i o n Arthropathy is commonly
observed in patients with IBD. In daily practice,
peripheral arthritis, axial arthritis or a
combination of both is observed. The prevalence
has been reported up to 25 of patients with
Crohns disease (CD) and 15 of patients with
Ulcerative Colitis (UC). In addition
enthesiopathy may be found in 5-10. Arthralgia
as isolated symptom is found in 5.3 of patients
with UC and in 14.3 of patients with CD.
Occurrence of arthralgia may be induced due to
immunological reactions against intestinal
contents, as can be deduced from established
immunoserological reactions against bacteria in
combination with increased intestinal
permeability. NSAID/ COX2 inhibitors are often
efficacious, but may induce a flare-up of IBD.
Our aim was to study the safety and efficacy of
VSL3 in an open label trial in patients with
quiescent IBD, suffering from arthralgia for at
least 2 weeks.
R e s u l t s A significant decrease of the
Ritchie score from 13.4 to 6.6 (p lt 0.01) was
observed. There were 12 withdrawals, due to
distaste (2), spontaneous improvement (3),
deterioration of general well-being
Three strains Bifidobacterium B. longum
B. infantis B. brevis
VAS II score indicated the general well being of
the patients at the moment of assessment. The
average score was 63 (SD25) at the start of the
study and 70 (SD30) at the end of the study.
One strain Streptococcus S. salivarius
subsp. Thermophilus
IBD activity was assessed by Truelove-Witts or
Harvey-Bradshaw score.
Arthralgia was assessed by the Ritchie score
(joints assessed separately and graded for
tenderness on a 0-3 scale) at baseline and at
week 12.
which was not IBD related (2), and non-specific
gastrointestinal symptoms (5). In contrast, five
patients reported improvement of gastrointestinal
symptoms, with concomitant increase of general
well-being.
C o n c l u s i o n In general, the VAS score was
low on average, indicating that arthralgia
constitutes a significant clinical burden. These
preliminary study results suggest improvement of
arthralgia in a subset of patients with quiescent
IBD due to VSL3. Apparently, the intestinal
contents do influence the condition of joints in
IBD patients. About 30 of patients had adverse
events, mainly related to the taste of the
product, and which had no effect on the course of
IBD. To confirm these data, a randomized
placebo-controlled trial is scheduled for the
near future.
General well being was assessed by the Visual
Analogue Scale.
t 12 weeks
t 0
t 6 weeks
M e t h o d s In 29 patients with quiescent IBD
and arthralgia with stable medical therapy, VSL3
sachets b.i.d. was prescribed for 3 months. One
sachet contained 450 billion viable lyophilised
bacteria of 4 strains of Lactobacillus, 3 strains
of Bifidobacterium, and one strain of
Streptococcus salivarius subsp. Thermophilus.
Telephone
Phys exam Assessment arthralgia/IBD LAB
Phys exam Assessment arthralgia/IBD LAB
Rx VSL3 b.i.d.
So far, 17 of 29 patients received VSL3 for more
than one week, of which 12 patients completed the
trial. The sex distribution was 10 females and 2
males with a period of disease varying from 3 to
36 years. There were 9 cases of CD and 3 cases of
UC. Five patients had a surgical history.
VAS I score indicated the general well- being of
the patients in the week before assessment. The
average score was 54 (SD22) at the start of the
study and 58 (SD27) at the end of the study.
Four strains Lactobacillus L. acidophilus
L. casei L. delbruckei subsp.
bulgaricus L. plantarum