Evidence map›Paper›PMID 42884705›Full record

Trial reportNutrients2026

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 Tzikos, Alexandra-Eleftheria Menni, Ioannis M Theodorou, Helen Theodorou, Joulia K Tsetis, Eleni Chamalidou, George Stavrou, Anne D Shrewsbury, Amalia Bolanou, Aristeidis Ioannidis and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nutrients, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06496438 (Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06496438 naunknown statusnot on this map

Psychobiotics Ameliorate Anxiety and Depression Status in Patients Under Chemotherapy for Gastrointestinal Malignancies

TypeinterventionalSponsorAristotle University Of ThessalonikiRan2023 to 2025Enrolled270ConditionsDepression, Anxiety Disorder, Probiotics, Gastrointestinal CancerArmsPsychobiotics, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Georgios G TzikosDepartment of Surgery, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.ORCID 0000-0003-1095-8709
Alexandra-Eleftheria MenniDepartment of Surgery, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.ORCID 0000-0002-4978-1042
Ioannis M TheodorouHellenic Institute for the Study of Sepsis (HISS), 11528 Athens, Greece.ORCID 0009-0006-3526-194X
Helen TheodorouDepartment of Sociology, School of Social Sciences, University of Crete, 74100 Rethymno, Greece.ORCID 0009-0002-4880-0069
Joulia K TsetisUni-Pharma S.A., 14564 Athens, Greece.
Eleni ChamalidouOutpatient Surgical Oncology Unit, Chemotherapy Department, AHEPA University Hospital, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.
George StavrouDepartment of Surgery, 417 NIMTS (Army Share Fund Hospital), 11521 Athens, Greece.ORCID 0000-0001-5948-8037
Anne D ShrewsburyDepartment of Surgery, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.
Amalia BolanouHellenic Institute for the Study of Sepsis (HISS), 11528 Athens, Greece.
Aristeidis IoannidisDepartment of Surgery, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.ORCID 0000-0003-3865-6358
Katerina KotzampassiDepartment of Surgery, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece.ORCID 0000-0003-0241-7216

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesPatients 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.

methodsParticipants 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.

resultsThe 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

conclusionsPsychobiotic 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.

Indexed as

Gastrointestinal NeoplasmsMental HealthProbioticsQuality of LifeAdultAgedChemotherapy, AdjuvantDouble-Blind MethodFemaleHumansLongitudinal StudiesMaleMiddle AgedSurveys and QuestionnairesTreatment Outcomeadjunctive therapychemotherapygastrointestinal cancergut–brain axisHR-QoLpost hoc analysispsychobioticsSF-36 questionnairesurgical oncology

Identifiers

PMID42884705
PMCPMC13666839

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.