RecruitingPhase 1NCT07477522

Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study


Sponsor

West China Hospital

Enrollment

25 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Cancer remains a major global public-health challenge and a central focus of medical research. According to the International Agency for Research on Cancer (IARC, 2020), 19.29 million new malignant tumors and 9.96 million cancer deaths occurred worldwide, \>90 % being solid cancers. Lung cancer alone accounted for 2.2 million new cases and 1.8 million deaths; \>75 % of patients were already at an advanced stage at diagnosis. Current options for late-stage solid tumors are limited: surgery is often impossible because of metastasis; cytotoxic chemotherapy produces dose-limiting toxicities (grade Ⅲ-Ⅳ myelosuppression 15-40 %, mucositis 50-80 %); radiotherapy risks pneumonitis (5-15 %) or enteritis (5-20 %) when tumors abut vital organs; targeted agents succumb to acquired resistance after a median 9-13 months; and immune-checkpoint inhibitors achieve \<40 % objective response with 7-15 % grade 3-4 immune-related adverse events. Dietary intervention is therefore emerging as a promising adjunct. Dietary fibre protects against cardiovascular and metabolic diseases, yet intake is universally low. WHO and the Chinese Nutrition Society recommend 25-30 g total fibre per day (≈15-21 g insoluble), whereas Chinese adults consume only \~11 g insoluble fibre. High-fibre diets reshape gut microbiota, augment short-chain fatty acid (SCFA) production, strengthen intestinal barrier function, activate CD8⁺ T cells and dampen regulatory T cells, thereby enhancing anti-tumour immunity. A melanoma cohort showed improved progression-free survival under immunotherapy when fibre intake was high. Similar microbiota-immune axes may operate in colorectal and other solid cancers, but clinical data are scarce. We therefore propose a study to examine whether a high-insoluble-fibre diet (\>21 g/day) modulates gut-microbiota composition, metabolite profiles and peripheral-blood immune subsets in solid-tumour patients, and to evaluate consequent effects on treatment response and quality of life. The findings will clarify whether fibre-driven microbiota-immune crosstalk can be harnessed as a personalised nutritional strategy to improve cancer outcomes.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a high-fiber diet can improve gut bacteria, metabolism, and the immune environment in people with solid tumors (cancers that form lumps, not blood cancers). Researchers believe what you eat may affect how your immune system fights cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with a solid tumor (confirmed by biopsy) - You have at least one measurable tumor that can be tracked - You are in good general health (ECOG score of 0–1, meaning you can carry out normal activities) - You are not severely malnourished (nutrition screening score below 3) - Your blood counts, liver, and kidney function meet required levels - You are able to eat normally or through a feeding tube **You may NOT be eligible if...** - You are severely malnourished - Your blood counts or organ function do not meet the required levels - You cannot eat or tolerate enteral nutrition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTHigh-fibre diet

Dietary fibre, recommended at 25-30 g/d (15-21 g insoluble), is chronically under-consumed (\~11 g/d in China). High-fibre diets increase SCFAs, enhance gut-barrier integrity and boost anti-tumour immunity, correlating with better immunotherapy outcomes in melanoma. Clinical evidence in solid tumours is lacking. Our trial will test whether \>21 g/d insoluble fibre reshapes microbiota, metabolites and immune markers in solid-cancer patients and improves treatment response and quality of life, providing rationale for microbiota-targeted nutrition.


Locations(1)

West China Hospital

Chengdu, Sichuan, China

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NCT07477522


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