Digestive CancerONCONUTRIBIOTANCT07260617
Association Between Composition of the Gut Microbiota and Nutritional Status in Digestive Oncology
An observational study of Digestive Cancer, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Cancer
- What is being tested?
- Not applicable- observational study
- How many people
- 150 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with chemotherapy in digestive oncology
Who may be able to join
- Adult patient
- Patient with digestive cancer, including:
- Borderline or locally advanced pancreatic adenocarcinoma
- Metastatic pancreatic adenocarcinoma without symptomatic peritoneal carcinomatosis
- metastatic colon/rectal cancer without symptomatic peritoneal carcinomatosis
- Patients with an indication for chemotherapy (induction treatment or treatment of metastatic disease)
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- Patients able to eat orally at the time of inclusion in the study
- Patients with a performance status (PS) score ≤2
- Patients who agree to provide stool and saliva samples
- Patients who have given their written informed consent
- Patients affiliated with the French social security system
Who cannot join
- Pregnant or breastfeeding women
- Patients who have received antibiotics within 3 weeks prior to the first chemotherapy treatment (excluding antibiotic prophylaxis administered in the context of surgery or endoscopy).
- Individuals receiving psychiatric care that may interfere with their ability to respond to questionnaires (in the investigator's opinion)
- Persons deprived of their liberty or subject to legal protection measures (guardianship, curatorship)
- Patients participating in another interventional study with medication
- Patients who have undergone chemotherapy for another malignant tumor in the last 12 months.
Show all 10Show fewer
- Patients with another synchronous malignant tumor, with the exception of adequately treated carcinoma in situ of the cervix or squamous cell carcinoma of the skin, or limited basal cell or squamous cell skin cancer. This cancer must then be adequately controlled.
- Patients with symptomatic brain and/or meningeal metastases.
- Patients who have undergone digestive resection (excluding appendectomy or cholecystectomy >12 months ago).
- Patients with symptomatic peritoneal carcinomatosis prior to the start of chemotherapy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Edouard Herriot Hospital - medical oncology department
Lyon, 69003
Laura Gerard, Dr, +334 72 11 91 67, Laura.gerard@chu-lyon.fr
Croix Rousse Hospital Hepatology and Gastroenterology Department
Lyon, 69004
Nicolas Benech, Dr, +334 26 10 94 35, Nicolas.benech@chu-lyon.fr
Lyon Sud Hospital - Hepatology and Gastroenterology Department
Lyon, 69310
Gilles Boschetti, Dr, +334 78 86 38 66, gilles.boschetti@chu-lyon.fr
About this study
Official title: Study of the Association Between the Composition of the Gut Microbiota and Nutritional Status in Patients Treated With Chemotherapy in Digestive Oncology
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.
Read more
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.
- Conditions
- Digestive Cancer
- Being tested
- Not applicable- observational study
- Keywords
- oral and fecal microbiota, digestive cancer, colorectal cancer, pancreatic cancer, chemotherapy, malnutrition, microbiome
- Medical subject headings
- Gastrointestinal Neoplasms, Colorectal Neoplasms, Pancreatic Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Observational arm of cancer patients starting chemotherapy | 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. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Secondary outcomes (12)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Benech, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260617
- Sponsor's protocol ID
- 69HCL25_0613
- Other IDs
- 2025-A02021-48
- Acronym
- ONCONUTRIBIOTA
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between the Composition of the Gut Microbiota and Nutritional Status in Patients Treated With Chemotherapy in Digestive Oncology
- ClinicalTrials.gov ID
- NCT07260617
- Acronym / sponsor ID
- ONCONUTRIBIOTA / 69HCL25_0613
- Conditions
- Digestive Cancer
- Keywords
- oral and fecal microbiota, digestive cancer, colorectal cancer, pancreatic cancer, chemotherapy, malnutrition, microbiome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational arm of cancer patients starting chemotherapy | – | Other: Not applicable- observational studyDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with chemotherapy in digestive oncology
Key inclusion criteria (11 listed)
- Adult patient
- Patient with digestive cancer, including:
- Patients with an indication for chemotherapy (induction treatment or treatment of metastatic disease)
- Patients able to eat orally at the time of inclusion in the study
- Patients with a performance status (PS) score ≤2
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
- Patients who have received antibiotics within 3 weeks prior to the first chemotherapy treatment (excluding antibiotic prophylaxis administered in the context of surgery or endoscopy).
- Individuals receiving psychiatric care that may interfere with their ability to respond to questionnaires (in the investigator's opinion)
- Persons deprived of their liberty or subject to legal protection measures (guardianship, curatorship)
- Patients participating in another interventional study with medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyDuring 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) | Other | Observational arm of cancer patients starting chemotherapy |
Primary outcome
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.
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
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).
12 secondary outcomes
Difference in oral microbiota composition before and after chemotherapy treatment
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
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
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
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
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
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
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
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
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
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
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
Time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Benech, Dr principal investigator
Hospices Civils de Lyon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive Cancer, run by Hospices Civils de Lyon at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Benech, Dr (+334 26 10 94 35, Nicolas.benech@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.