Association Between Composition of the Gut Microbiota and Nutritional Status in Digestive Oncology

NCT07260617 | Not Yet Recruiting

• 2 other identifiers: 69HCL25_06132025-A02021-48
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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 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.

Conditions

Digestive Cancer

Keywords

oral and fecal microbiota; digestive cancer; colorectal cancer; pancreatic cancer; chemotherapy; malnutrition; microbiome

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  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

  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

  at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy

• Change in nutritional parameters during chemotherapy

  at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy

Study Arms (1)

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.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

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)

Observational arm of cancer patients starting chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with chemotherapy in digestive oncology

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Edouard Herriot Hospital - medical oncology department

Lyon, 69003, France

Location

Croix Rousse Hospital Hepatology and Gastroenterology Department

Lyon, 69004, France

Location

Lyon Sud Hospital - Hepatology and Gastroenterology Department

Lyon, 69310, France

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Malnutrition

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Nicolas Benech, Dr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Benech, Dr

CONTACT

+334 26 10 94 35; Nicolas.benech@chu-lyon.fr

Alexandra Fournier

CONTACT

+334 78 86 22 09; alexandra.fournier@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

FR (3)