Nascimento_2019

Referenz

(Autor, Jahr, Journal)

Studientyp

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

Patienten-merkmale

Indikation, Alter, Geschlecht (m/w)

Intervention

Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme

Kontrolle

Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme

Zielgrößen

Primärer Endpunkt

Sekundäre(r) Endpunkt(e)

Primärer Endpunkt

Angaben für Intervention vs. Kontrolle

Sekundäre(r) Endpunkt(e)

Angaben für Intervention vs. Kontrolle

Finanzierung

Evidenzstufe

Bei Abwertung: Angabe von Gründen

Bewertung des Autors

Nascimento

2019

Nutrition and Cancer

Randomized, Double-Blind, Placebo-Controlled Pilot Trial

N = 21

three-dimensional conformal radiotherapy for prostate cancer

dose of 2 Gy per day, from Monday to Friday

Symbiotic group

Age (y/o): 64.3 (7,5)

BMIa (kg/m2): 27.4 (3.8)

Placebo group

Age (y/o): 70.4 (8.3)

BMIa (kg/m2): 30.0 (5)

N = 10

synbiotic powder containing Lactobacillus reuteri (108 CFU) and soluble fiber (4.3 g)

N = 10

placebo

intensity of proctitis symptoms

level of fecal calprotectin

proctitis symptoms plus quality of life scores

Symbiotic group vs. Placebo group

Before: 21 (21–25) vs. 21 (21–31), p= 0.85

Fifth week: 22 (21–34) vs. 26 (21–47), p=0.035

Sixth week: 21 (21–33) vs. 29 (21–35), P=0.017

Seventh week: 22.5 (21–31) vs. 24 (21–39), P= 0.23

proctitis symptoms scores

Symbiotic group vs. Placebo group

Before: 15 (15–19) vs. 15 (15–23), p= 0.8

Fifth week: 16 (15–24) vs. 20 (15–33), p= 0.043

Sixth week: 15 (15–21) vs. 19 (15–26); P=0.043

Seventh week: 16 (15–21) vs. 18 (15–27); p=0.23

Nonsignificant evolution (P = 0.44) of fecal calprotectin in symbiotic group and significant increase (P = 0.028) in the placebo group.

no difference in CRP/albumin ratio (P = 0.78) between the placebo (median: 1.08, range: 0.24–4.83) and symbiotic group (median: 0.73, range: 0.17–1.95).

This work was supported by CNPq (Brazilian National

Council for Scientific and Technological Development)

(grant number 472881/2011-6).

2

small sample size
no data either from endoscopic or histopathological status of rectal mucosa, and also no data about the microbiome of each individual

"Synbiotics reduce proctitis symptoms and improve quality of life by preventing rectal inflammation during radiotherapy for prostate cancer."