Giralt 2008

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

Giralt 2008

International Journal of Radiation Oncology

Monocenter

Placebo-controlled, double-blind, randomized clinical trial

Two arms

N= 85

Spain

11/2002-12/2005

Cervical carcinoma (RTX and weekly Cisplatin), endometrial adenocarcinoma (postoperative RTX)

60.9±11.8 vs. 59.3±12.7 yrs.

Female

1.8–2 Gy/d, five times weekly for 5–6 weeks

N= 44

Probiotic drink containing Lactobacillus casei DN-114 001 at 108 CFU/g 96 ml three times daily (fermented liquid yoghurt)

N= 41

Placebo prepared by sterilizing the active product

Primary endpoint:  Proportion of nonresponders

(grade ≥2 diarrhea [NCI-CTCAE], need for rescue medication,withdrawal because of lack of efficacy)

Secondary Endpoints: time to develop grade 2 diarrhea, interval to first occurrence of Type 5,6 or 7 stools (Bristol Scale), quality of life, safety

Nonresponder (30/44 [68.2 %] vs. 24/41 [58.5 %])

Grade ≥3 diarrhea (20/44 [45.5 %] vs. 15/41 [36.6 %])

Rescue medication (16/44 [36.4 %] vs. 12/41 [29.3 %])

Bristol Scale

Type ≥5 (soft or worse) (41/42 [97.6 %] vs. 41/41 [100 %])

Type ≥6 (fluffy or worse) (41/42 [97.6 %] vs. 41/41 [100 %])

Type 7 (watery) (35/42 [83.3 %] vs. 34/41 [82.9 %])

Study product was well tolerated, none of the adverse events reported was considered related

No information

1b/1+

“Nutritional intervention with the probiotic drink containing L.casei DN-114001 does not reduce the incidence of radiation-induced diarrhea… however, it had a significant effect on stool consistency…”