Journal reading, 11th August 2016 World J Gastroenterol 2015 May 21; 21(19): 5985-5994

Nico Aldrin, Ratna Agustina

Internal Medicine Department RSAY

Effectiveness Of Probiotic Therapy For The Prevention

Of Relapse In Patients With Inactive Ulcerative Colitis
Yoshimatsu Y, Yamada A, Furukawa R, Sono K, Osamura A, Nakamura K et all

BACKGROUND
to evaluate the effectiveness of probiotic therapy for suppressing relapse in patients with inactive ulcerative
colitis (UC).

METHODS
Bio-Three tablets, each containing 2 mg of lactomin (Streptococcus faecalis T-110), 10 mg of Clostridium
butyricum TO-A, and 10 mg of Bacillus mesentericus TO-A, were used as probiotic therapy. Sixty
outpatients with UC in remission were randomly assigned to receive 9 Bio-Three tablets/day (BioThree
group) or 9 placebo tablets/day (placebo group) for 12 mo in addition to their ongoing medications. Clinical
symptoms were evaluated monthly or on the exacerbation of symptoms or need for additional medication.
Fecal samples were collected to analyze bacterial DNA at baseline and 3-mo intervals. Terminal restriction
fragment length polymorphism and cluster analyses were done to examine bacterial components of the
fecal microflora.

RESULTS
Forty-six patients, 23 in each group, completed the study, and 14 were excluded. The relapse rates in the
Bio-Three and placebo groups were respectively 0.0% vs 17.4% at 3 mo (P = 0.036), 8.7% vs 26.1% at 6
mo (P = 0.119), and 21.7% vs 34.8% (P = 0.326) at 9 mo. At 12 mo, the remission rate was 69.5% in the
Bio-Three group and 56.6% in the placebo group (P = 0.248). On cluster analysis of fecal flora, 7 patients
belonged to cluster, 32 to cluster , and 7 to cluster .

CONCLUSIONS
Probiotics may be effective for Randomized Clinical Trial maintaining clinical remission in patients with
quiescent UC, especially those who belong to clusteron fecal bacterial analysis.
 Critical appraisal

1. Are the result of this individual study valid? Yes

a. Was the assignment of patient to treatment randomized? Yes
b. Was the randomized concealed ? Yes
c. Were the group similar at the strat of the trial? Yes
d. Was the follow up of patient sufficiently long and complete ? Yes
e. Were all patient analyzed in the group to which they were randomized ? Yes
f. Were patient, clinicians and study personel kept blind to treatment? Yes
g. Were group treated equally, apart from the experimental therapy? Yes

2. Are the valid results of this individual study important?

Was is the magnitude of the treatment effect?
End point Bio-Three Placebo Hazard Ratio P value
tablets (N=23) (N=23) (95% CI)
3 Month Relaps 0% (0) 17,4% (4) 0.036
6 Month Relaps 8,7% (2) 26,1% (6) 0.119
0,23-1,59
9 Month Relaps 21,7% (5) 34,8% (8) 0.326
12 Month Relaps 69,5% (7) 56,6% (10) 0.248
In this trial involving grup that were given bio-three decrease relapse rates and increase
remission rate in colitis ulserative compared with the group given placebo within 12
month . The relaps rate in Bio-Three and placebo groups were respectively 0% and 17,%
at 3 months, 8,7% and 26,1% at 6 months, and 12,7% and 34,8% at 9 months. At 12
months, the remission rate was 69,5% in Bio-Three group and 56,6% in the placebo
group.

3. Are the valid important results of this individual study applicable to our patient?
a. Is our patient so different from those in the study that its results cannot apply?
No. The baseline characteristicc are similar.
b. Is the treatment feasible in our setting? Yes.
c. What our patients potential benefits and harms from the therapy? The potential
benefits and harms will similiar as this study group
d. What are our patients values and expectations of both the outcome we are trying
to prevent and the treatment we are offering?
probiotics may be effective for maintaining clinical remission in patients with quiescent
UC.