Delia 2007

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

Delia 2007

World Journal of Gastroenterology

Monocenter

Double-blind, placebo-controlled, parallel-group study

Two arms

N= 490

Italy

05/1999-12/2005

Adjuvant postoperative radiation therapy after surgery for sigmoid, rectal or cervical cancer

N= 243

VSL#3 (450 billions/g of viable lyophilized bacteria Lactobacillus, Bifidobacteria and Streptococcus) one sachet t.i.d. from the first day of RTX until the end of therapy

N= 239

Identical appearing placebo, same schedule

Incidence and severity of radiation-induced diarrhea (WHO Grading)

Daily number of bowel movements

Time until use of loperamide as rescue medication

Radiation-induced diarrhea (77/243 [31.6 %] vs. 124/239 [51.8 %])

Grade 3-4 Diarrhea (3/243 [1.4 %] vs.132/239 [55.4 %])

Daily bowel movements (5.1±3 vs. 14.7±6)

Mean time to use loperamide after the start of the study (122±8 h vs. 86±6 h)

Placebo withdrawal: severe diarrhea (6 patients)

No tumor- or treatment-related deaths

No case of bacteremia, sepsis, septic shock due to lactobacilli

No information

1b-/1+

Missing baseline data

“Probiotic lactic acid-producing bacteria are an easy, safe and feasible approach to protect cancer patients against the risk of radiation-induced diarrhea.”