An observational study in Digestive Cancer, sponsored by Hospices Civils de Lyon. Not yet recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Hospices Civils de Lyon · Observational
Nutritional status represents a crucial issue in the management of cancer patients, as between 40% and 60% of them suffer from malnutrition at the time of diagnosis. This condition worsens morbidity, increases treatment-related adverse effects, infections, and hospitalizations, and can lead to death in 10% to 20% of cases, independently of tumor progression. Anticancer treatments often exacerbate malnutrition due to their side effects, such as loss of appetite or taste alterations.
Although international guidelines (ESPEN, ESMO, ASCO) recommend a multimodal nutritional intervention combining nutritional support and physical activity. The effectiveness of these approaches varies among patients. This variability can be explained by several factors, including individual differences in dietary intake response, metabolic status, and digestive tolerance to treatments.
The intestinal and oral microbiota appear to be key cofactors in regulating these various parameters, influencing appetite, host metabolism, and intestinal absorption. Alterations in the microbiota-particularly a decrease in bacterial diversity and an increase in Candida albicans-have been associated with appetite loss and taste perception disorders, especially in patients with digestive cancers. Therefore, the intestinal microbiota constitutes a potential therapeutic and diagnostic target to improve nutritional strategies in oncology.
Interventions targeting the microbiota (such as probiotic supplementation or fecal microbiota transplantation) have already demonstrated an impact on nutritional parameters in preclinical models of malnourished cancer-bearing mice; however, clinical data remain scarce and limited.
The ONCONUTRIBIOTA-cohort study aims to characterize and investigate the oral and intestinal microbiota of patients initiating chemotherapy for digestive cancer, in relation to their nutritional status clinical characteristics and food preferences, in order to identify potential biomarkers or therapeutic targets to optimize their nutritional management.
Patients will be followed during two of their routine care visits: on the day of the first chemotherapy treatment and at the end of the first cycle of chemotherapy. During these visits, stool and saliva samples will be collected, completed by additional assessments including global quality of life and nutritional quality of life questionnaires, olfactory and gustatory tests, and measurements of parameters used to determine the presence of malnutrition, general health status and oncological evaluation.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's planned enrollment of 150 is below the median of 197 across 176 observational studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated with chemotherapy in digestive oncology
Patient with digestive cancer, including:
During two of their routine care visits (on the day of the first chemotherapy treatment and at the end of the first cycle of chemotherapy) stool and saliva samples will be collected, completed by additional assessments including global quality of life and nutritional quality of life questionnaires, olfactory and gustatory tests, and measurements of parameters used to determine the presence of malnutrition, general health status and oncological evaluation.
Other: Not applicable- observational study
During two routine care visits - on the day of the first chemotherapy administration and at the end of the first chemotherapy cycle - stool and saliva samples will be collected. These will be complemented by additional assessments, including global and nutritional quality of life questionnaires, olfactory and gustatory tests, and measurements of parameters related to malnutrition, general health status, and oncological evaluation (including blood sampling and specific analyses based on the radiological assessments performed as part of routine care)
Difference in fecal microbiota composition, assessed by beta-diversity (Weighted UniFrac and Bray-Curtis) based on shotgun metagenomic data, between patients with severe, moderate, or no malnutrition evaluated at V1 and V2.
The difference in fecal microbiota composition, measured by beta-diversity (Weighted UniFrac and Bray Curtis) from shotgun metagenomic data, between patients with severe, moderate, and no malnutrition assessed at V1 (before 1st cure of chemotherapy) and V2 (after the first cycle of chemotherapy). Malnutrition is defined according to GLIM recommendations by the combination of the etiological criterion of active neoplasia common to all patients included, associated with a phenotypic criterion (BMI, weight loss, sarcopenia according to a standardized method).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Difference in oral microbiota composition before and after chemotherapy treatment
The difference in oral microbiota composition, measured by beta-diversity (Weighted UniFrac and Bray Curtis) on shotgun metagenomic data, between malnourished and non-malnourished patients (GLIM criteria) assessed at V1 (before 1st cure of chemotherapy) and V2 (after 4 cures of chemotherapy).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Variation in the taxonomic and functional composition of the oral and fecal microbiota
Variation in the taxonomic and functional composition of the oral and fecal microbiota (analysis by beta-diversity and differential taxa and metagenomics) between V1 (before 1st cure of chemotherapy) and V2 (after 4 cures of chemotherapy).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Fecal and oral metabolomic signatures associated with malnutrition status
Fecal and oral metabolomic signatures associated with malnutrition status Identification of fecal and oral metabolomic signatures (by LC-MS or GC-MS) associated with malnutrition status assessed at V1 (before 1st cure of chemotherapy) and V2 (after 4 cures of chemotherapy).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Correlation between taxonomic profiles and markers of nutritional status
Correlation between taxonomic profiles (relative abundance of bacterial taxa) and markers of nutritional status (BMI, weight loss, prealbumin, albumin, CRP) at V1 and V2; calculation of Spearman's coefficient with false positive control (FDR).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Change in nutritional parameters during chemotherapy
Change in BMI, relative weight loss, estimated nutritional intake (24-hour survey), appetite (SEFI scale), and biological markers (albumin, prealbumin, CRP) between V1 and V2.
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Intra-individual variation in blood markers of nutritional status
Intra-individual variation in markers of nutritional status (GLIM nutritional diagnosis, prealbumin, albumin) and appetite (SEFI scale) between V1 and V2, depending on the type of chemotherapy.
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Change in sensory scores during chemotherapy
Variation in sensory scores between V1 and V2, assessed using validated questionnaires (CITAS/SA-Quest, Self-reported food appreciation).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Correlation between sensory scores and nutritional status markers
Correlation between sensory scores and nutritional status markers (GLIM criteria, albumin, SEFI) at V1 and V2 (Spearman coefficient calculation with false positive control -FDR).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Correlation between sensory scores and the composition of oral and fecal microbiota
Correlation between sensory scores and the composition of oral and fecal microbiota at V1 and V2 (alpha/beta diversity, relative abundances of different taxa with calculation of Spearman's coefficient with false positive control -FDR).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Correlation of patients' quality of life with the composition of oral and fecal microbiota
Correlation of patients' quality of life (EORTC QLQ-C30 questionnaire (version 3) with the composition of oral and fecal microbiota at V1 and V2 (alpha/beta diversity, relative abundances of different taxa with calculation of Spearman's coefficient with false positive control -FDR).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Correlation between sensory scores and quality of life score
Correlation between sensory scores (CITAS/SA-Quest, Self-reported food appreciation) and quality of life score (according to EORTC QLQ-C30 (version 3)) at V1 and V2 (Spearman's coefficient calculation with false positive control -FDR).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Correlation between nutritional status markers and quality of life score
Correlation between nutritional status markers (BMI, weight loss, SEFI, albumin, CRP) and quality of life score (according to EORTC QLQ-C30 (version 3)) at V1 and V2 (Spearman's coefficient calculation with false positive control -FDR).
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospices Civils de Lyon