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Peer-reviewedCC BYNutrients

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

  • Georgios G. Tzikos1
  • Alexandra-Eleftheria Menni1
  • Ioannis M. Theodorou2
  • Helen Theodorou3
  • Joulia K. Tsetis4
  • Eleni Chamalidou5
  • George Stavrou6
  • Anne D. Shrewsbury1
  • Amalia Bolanou2
  • Aristeidis Ioannidis1
  • Katerina Kotzampassi1
6 affiliations
  1. 1Department of Surgery, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
  2. 2Hellenic Institute for the Study of Sepsis (HISS), 11528 Athens, Greece
  3. 3Department of Sociology, School of Social Sciences, University of Crete, 74100 Rethymno, Greece
  4. 4Uni-Pharma S.A., 14564 Athens, Greece
  5. 5Outpatient Surgical Oncology Unit, Chemotherapy Department, AHEPA University Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
  6. 6Department of Surgery, 417 NIMTS (Army Share Fund Hospital), 11521 Athens, Greece
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Abstract

Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.

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Cite

BibTeXRIS
BibTeX
@article{tzikos2026longitudinal,
  title = {{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}},
  author = {Georgios G. Tzikos and Alexandra-Eleftheria Menni and Ioannis M. Theodorou and Helen Theodorou and Joulia K. Tsetis and Eleni Chamalidou and George Stavrou and Anne D. Shrewsbury and Amalia Bolanou and Aristeidis Ioannidis and Katerina Kotzampassi},
  journal = {Nutrients},
  year = {2026},
  month = oct,
  doi = {10.3390/nu18193254},
  url = {https://europepmc.org/article/PMC/PMC13666839},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - 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
AU  - Georgios G. Tzikos
AU  - Alexandra-Eleftheria Menni
AU  - Ioannis M. Theodorou
AU  - Helen Theodorou
AU  - Joulia K. Tsetis
AU  - Eleni Chamalidou
AU  - George Stavrou
AU  - Anne D. Shrewsbury
AU  - Amalia Bolanou
AU  - Aristeidis Ioannidis
AU  - Katerina Kotzampassi
PY  - 2026
DA  - 2026/10/01
JO  - Nutrients
DO  - 10.3390/nu18193254
UR  - https://europepmc.org/article/PMC/PMC13666839
AB  - Background/Objectives: 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. Methods: 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. Results: 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. Conclusions: 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.
SN  - 2072-6643
ER  -