Clinical trial · Observational
Gut Microbiota (GM) Biodiversity in Patients With Solid Tumors Treated With Immune Checkpoint Inhibitors (ICIs): a Monocenter Prospective Study to Identify the Interactions Between GM and ICIs
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Although it is a milestone in the treatment of solid neoplasms, Immunotherapy (ICI) is still burdened by low response rate to the treatment and the occurrence of immune-related adverse events (irAEs). Recently, many studies have suggested that the The diversity of the intestinal microbiota (GM) can modulate response to ICIs \[1\]. The GM would be able to produce several molecules that can influence the growth of cancer cells and modulate anti-cancer immunity. Our project aims to investigate changes in the subject and its relationship to immunotherapy. Dynamic changes in cytokines can be a indicator of increased or decreased toxin translocation bacterial and therefore of the greater or lesser integrity of the barrier intestinal. Define the influence of diet on changes in GM can also help us understand how to modify these factors to improve the outcome of the subject undergoing immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor Cancer Treatment With Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The difference in alfa and beta diversity of GM in the stool sample
- timeFrame
- After 3 weeks, after 12 weeks, after 24 weeks and in the case of progression disease
Secondary outcomes (5)
- measure
- The difference in alfa and beta diversity of GM in the stool sample
- timeFrame
- From time 0, baseline (at the start of ICIs) to the occurrence of irAEs
- measure
- The difference in the cytokine profile in the blood sample
- timeFrame
- From time 0 baseline (at the start of ICIs) to the different time points (after 3 weeks, after 12 weeks, after 24 weeks and in the case of progression disease)
- measure
- The predictive factors associated with response to treatment with ICIs will be measured related to QueMD questionnaire score for adherence to Mediterranean diet at baseline, difference in QueMD questionnaire score from baseline to week 12.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients aged ≥18 years 2. Life-expectancy ≥6 months; 3. All participants have signed the consent form before enrollment 4. Patients with cancer who have to start immunotherapy with or without chemotherapy/targeted therapy Exclusion Criteria: 1. Patients reporting an intake of antibiotic therapy during the last 30 days (rifaximin therapy used in patients with hepatocellular carcinoma in order to decrease the occurrence of overt Hepatic Encephalopathy is permitted) or any probiotic therapy in the last 30 days 2. A personal history of autoimmune or inflammatory bowel disease 3. Any major intestinal surgery (including bariatric surgery) in the previous six months 4. Ongoing enteral or parenteral nutrition 5. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
References
Publications (0)
Data not yet available