Longitudinal Trajectories of Physical and Mental Health-Related Quality of Life Following Psychobiotic Supplementation in Gastrointestinal Oncology Patients: A Post Hoc Analysis of the ProDeCa Study.

Authors

Georgios G Tzikos, Alexandra-Eleftheria Menni, Ioannis M Theodorou, Helen Theodorou, Joulia K Tsetis, Eleni Chamalidou, George Stavrou, Anne D Shrewsbury, Amalia Bolanou, Aristeidis Ioannidis, Katerina Kotzampassi

Published in

Nutrients. Volume 18. Issue 19. Oct 02, 2026. Epub Oct 02, 2026.

Abstract

Patients undergoing surgery followed by adjuvant chemotherapy for gastrointestinal cancer frequently experience impaired health-related quality of life (HR-QoL). This post hoc analysis of the ProDeCa randomized trial investigated whether psychobiotic treatment was associated with longitudinal changes in HR-QoL.
Participants in the randomized, double-blind, placebo-controlled ProDeCa trial (NCT06496438) received either a four-strain psychobiotic formulation or placebo for four weeks during adjuvant chemotherapy. HR-QoL was assessed using the Short Form-36 (SF-36) questionnaire at baseline (V0), treatment completion (V1), and two months later (V2). Longitudinal changes in the eight SF-36 domains and the Physical (PCS) and Mental (MCS) Component Summary scores were analyzed using mixed models for repeated measures.
The present analysis included 266 participants, with HR-QoL data available for 231-232 participants at V2, depending on the SF-36 outcome. Significant group-by-visit interactions were observed across the eight SF-36 domains (all p < 0.001), indicating divergent longitudinal HR-QoL trajectories between treatment groups. Visit-specific adjusted comparisons generally favored psychobiotics; however, between-group differences in Vitality and Mental Health were not statistically significant at V1 and became significant at V2. At V2, the adjusted LS mean between-group differences were 16.79 points for PCS (95% CI, 15.69-17.88) and 9.66 points for MCS (95% CI, 8.49-10.84). Exploratory subgroup analyses did not provide evidence of differential treatment effects based on formal interaction tests.
Psychobiotic treatment was associated with more favorable longitudinal HR-QoL outcomes during adjuvant chemotherapy after gastrointestinal cancer surgery. These findings support further investigation of psychobiotics as an adjunctive strategy for HR-QoL support in larger multicenter randomized trials.

PMID:
42884705
Bibliographic data and abstract were imported from PubMed on 16 Oct 2026.

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