Efficacy of Synbiotics to Reduce Symptoms and Rectal Inflammatory Response in Acute Radiation Proctitis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

Nascimento M

Published in Nutrition and Cancer

Methodology

Randomised, double-blind, placebo-controlled pilot trial of a synbiotic during pelvic radiotherapy, assessing symptom scores and rectal inflammatory markers including faecal calprotectin.

Key Findings

In 20 patients with acute radiation proctitis, a synbiotic taken during pelvic radiotherapy did not significantly reduce diarrhoea, rectal bleeding or rectal inflammatory markers compared with placebo, although some symptom scores trended in favour of the synbiotic.

Conclusions

This pilot trial found no clear benefit of synbiotics for acute radiation proctitis; larger studies would be needed to detect modest effects.

Limitations

Pilot trial with only 20 participants and therefore very low power, short 7-week duration, heterogeneous radiotherapy protocols, and biomarker endpoints of uncertain clinical relevance.