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Safety and efficacy of Profermin® to induce remission in
ulcerative colitis.
Krag A1, Israelsen H, von Ryberg B, Andersen KK, Bendtsen F.
World J Gastroenterol. 2012 Apr 21;18(15):1773-80.
Abstract
AIM: To test the efficacy and safety of Profermin® in inducing remission in
patients with active ulcerative colitis (UC).
METHODS: The study included 39 patients with mild to moderate UC defined as
a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who
were treated open-label with Profermin(®) twice daily for 24 wk. Daily SCCAI
was reported observer blinded via the Internet.
RESULTS: In an intention to treat (ITT) analysis, the mean reduction in SCCAI
score was 56.5%. Of the 39 patients, 24 (62%) reached the primary endpoint,
which was proportion of patients with ≥ 50% reduction in SCCAI. Our secondary
endpoint, the proportion of patients in remission defined as SCCAI ≤ 2.5, was in
ITT analysis reached in 18 of the 39 patients (46%). In a repeated-measure
regression analysis, the estimated mean reduction in score was 5.0 points (95%
CI: 4.1-5.9, P < 0.001) and the estimated mean time taken to obtain half the
reduction in score was 28 d (95% CI: 26-30). There were no serious adverse
events (AEs) or withdrawals due to AEs. Profermin® was generally well
tolerated.
CONCLUSION: Profermin® is safe and may be effective in inducing remission of
active UC.
Profermin® til diætetisk behandling af
colitis ulcerosa og irritabel tyktarm
Profermin® er hverken kosttilskud eller
alternativ medicin
Profermin er udviklet med støtte fra Direktoratet
for Fødevareerhverv.
Profermin® er en fødevare til særlige medicinske
formål til diætetisk behandling af colitis ulcerosa
og irritabel tyktarm.
Profermin® er registreret hos Fødevarestyrelsen i henhold til reglerne i
fødevareloven og bekendtgørelsen om levnedsmidler til særlige
medicinske formål.
Effekten er dokumenteret ved kliniske studier publiceret i
anerkendte lægevidenskabelige tidsskrifter
Profermin® kan hjælpe cirka 2 ud af 3 patienter med colitis ulcerosa i
udbrud. Næsten halvdelen opnår remission. Der er ingen medicinske
bivirkninger.
Profermins effekt på colitis ulcerosa er dokumenteret ved 2 kliniske
studier med i alt 112 patienter.
De kliniske studier er designet og gennemført i samarbejde med 3 danske
overlæger og professorer samt lederen af statistikafdelingen hos
Kræftens Bekæmpelse.
Marts 2015
Resultaterne viser, at Profermin® har en effekt, der er både klinisk
relevant og statistisk signifikant på colitis ulcerosa i udbrud.
Resultaterne er publiceret her:


Krag A., Munkholm P., Israelsen H., von Ryberg B., Andersen
K.K., Bendtsen F.
”Profermin® is efficacious in patients with active ulcerative colitis
– a randomised controlled trial”
Inflamm Bowel Dis. 2013 Nov;19 (12):2584-92.
Krag A., Israelsen H., von Ryberg B., Andersen K.K., Bendtsen F.
”Safety and efficacy of Profermin® to induce remission in
ulcerative colitis”
World J Gastroenterol. 2012 Apr 21;18 (15):1773-80.
Abstract fra de 2 artikler ses på de følgende sider.
Overlæge, professor Aleksander Krag fra Odense Universitetshospital er
korresponderende hovedforfatter på begge artikler.
Profermin® har også god effekt på irritabel tyktarm, primært hvor
hovedsymptomet er diarré.
Mere information
For mere information om Profermin® og Nordisk Rebalance A/S se
hjemmesiden www.nordiskrebalance.dk.
Abstracts fra de 2 lægevidenskabelige artikler
Profermin is efficacious in patients with active ulcerative colitis a randomized controlled trial.
Krag A1, Munkholm P, Israelsen H, von Ryberg B, Andersen KK, Bendtsen
F
Inflamm Bowel Dis. 2013 Nov;19(12):2584-92
Abstract
BACKGROUND: Profermin is developed for the dietary management of
ulcerative colitis (UC). It consists of water, fermented oats, barley malt, lecithin,
and Lactobacillus plantarum 299v. The aim of this study was to assess the
clinical efficacy of Profermin.
METHODS: Seventy-four patients with a mild-to-moderate flare-up of UC
(defined as Simple Clinical Colitis Activity Index [SCCAI] score ≥5 and ≤11) were
randomly assigned to Profermin (n = 32) or Fresubin (n = 41). The primary
endpoint was to assess whether addition of Profermin in UC could significantly
reduce SCCAI in comparison with Fresubin.
RESULTS: In the run-in period, the mean SCCAI was 7.2 ± 1.50 in the Profermin
group and 7.6 ± 1.47 in the Fresubin group (not significant). After 8 weeks of
treatment, the mean reduction of SCCAI score was higher in the Profermin
group (mean difference: -1.77 SCCAI, 95% confidence interval -2.97 to -0.55; P <
0.005), in intention-to-treat analyses. Remission defined as SCCAI ≤2.5 was
achieved in 10 of 32 (31%) in the Profermin group and in 6 of 41 (15%) in the
Fresubin group (P = 0.048). The decrease in SCCAI scores of ≥50% was higher in
the Profermin group 17 of 32 (53%) versus 11 of 41 (27%) (P = 0.04). The risk of
dropping out due to treatment failure/lack of effect was higher in the Fresubin
group (42% versus 13%, P = 0.02).
CONCLUSIONS: Supplementation with Profermin is safe, well tolerated,
palatable, and able to reduce SCCAI scores at a statistically and clinically
significant level in patients with mild-to-moderate UC with a flare-up.