Urbancsek 2001

Referenz

(Autor, Jahr, Journal)

Studientyp

Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum

Patientenmerkmale

Indikation, Alter, Geschlecht (m/w), CTX

Intervention

Kontrolle

Zielgröße

Primary Endpoint

Secondary Endpoint

Finanzierung

Evidenzstufe (CEBM levels/ SIGN)

Bei Abwertung: Angabe von Gründen

Urbancsek 2001

European Journal of Gastroenterology & Hepatology

Two centers

Randomized, double-blind, parallel-group trial

Two arms

N= 205

Hungary

08/1996-06/1998

Irradiation in the lower abdomen (uterus or ovaries, prostate, rectum or miscellaneous malignancies of the lower abdomen)

28-86 yrs.

m/f

Daily doses about 2 Gy

N= 102

Lactobacillus rhamnosus sachets (containing 1,5 g L. rhamnosus equivalent to 1,5x10⁹ CFU)

3 times daily, suspended in water, 1 h after meals

N= 103 Placebo, identical appearing (corn starch, cellulose, iron oxide, orange, caramel aroma)

3 times daily, suspended in water, 1h after meals

Primary Endpoints: Time to and frequency of anti-diarrhoeal rescue medication

Secondary Endpoints: Number of bowel movements

Diarrhea Grading

Use of rescue medication (36/102 [35 %] vs. 49/103 [48 %])

Time to use rescue medication (138 h vs. 125 h)

Number of bowel movements at study start (6.4 vs. 6.6)

Number of bowel movements at study end (2.4 vs. 3.2)

Diarrhea grading study start (2.0 vs. 2.0)

Diarrhea grading study end (0.7 vs. 1.0)

Serious adverse events were not observed

Gastrointestinal problems (3/102 vs. 2/103)

Grant support and financial assistance by Germania Pharmazeutika GmbH, Vienna, Austria

1b-/1+

Used Diarrhea Grading not clear

“Overall, there was a highly favourable benefit/risk ratio in favour of Antibiophilus®.”