Actively Recruiting
Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
Led by West China Hospital · Updated on 2026-03-17
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cancer is a major global health challenge, with over 19 million new cases and nearly 10 million deaths worldwide annually, most being solid tumors such as lung cancer. Late-stage solid tumors have limited treatment options due to metastasis, treatment toxicities, and resistance to current therapies. Dietary fiber is emerging as a promising adjunct because it may improve immune responses and treatment outcomes by positively affecting gut microbiota and metabolism. This study evaluates a high-insoluble-fiber diet (more than 21 grams per day) in patients with solid tumors to see how it changes gut bacteria, metabolites, and immune system markers. Participants will follow this diet while researchers assess its safety and tolerability over six weeks. The study will also track treatment responses and quality of life up to one year. Participants will be monitored through laboratory tests, nutritional assessments, and immune profiling during the treatment period. Researchers will measure safety, tumor response rates, and duration of response. The study aims to clarify how dietary fiber affects cancer progression and treatment effectiveness, with follow-up lasting up to one year from enrollment.
CONDITIONS
Brief Title
Effects of High-Fiber Diet on Gut Microbiota, Metabolism, and Immune Microenvironment in Solid Tumor Patients: A Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study procedures.
- Males or females aged 18 to 80 years.
- Diagnosed with solid tumors confirmed by pathological tissue biopsy.
- At least one measurable lesion by RECIST v1.1 criteria (excluding lesions previously treated locally).
- ECOG Performance Status score of 0 to 1.
- Nutritional Risk Screening 2002 score less than 3.
- Body Mass Index 18.5 or higher (adjustable as needed).
- Able to eat orally or via feeding tube and tolerate enteral nutrition.
- Adequate organ function based on specified laboratory tests.
- Women of child-bearing potential must use contraception and have negative pregnancy test before treatment.
- Subjects at risk of pregnancy must use effective contraception during treatment and specified time after.
You will not qualify if you...
- Cognitive impairment or mental illness preventing understanding of the study.
- Central nervous system or meningeal metastases.
- Moderate or severe symptomatic ascites requiring recent paracentesis.
- Uncontrolled or moderate to severe pleural or pericardial effusion.
- Severe gastrointestinal conditions such as severe diarrhea, vomiting, malabsorption, intestinal obstruction, fistulas, or recent high-grade bleeding.
- Known allergy to study drug ingredients.
- Poorly controlled diabetes or hypertension.
- Severe cardiovascular or cerebrovascular diseases including recent stroke or heart attack.
- Pregnant or breastfeeding women.
- Other conditions deemed inappropriate by the investigator for enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants follow a high-fibre diet with more than 21 grams per day of insoluble fibre to assess its effects on gut microbiota, metabolism, and immune microenvironment in solid tumor patients.
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
Research Team
J
Jingwen Wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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