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Clinical Trials in China / NCT06649825
Enrolling by invitation Not applicable

Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

NCT06649825 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2024-01-08
Last updated
2026-04-24

Condition(s) studied

Familial Adenomatous Polyposis (FAP)

Investigational drug(s) / intervention(s)

Vitamin B1

Vitamin B1: Vitamin B1 tablets, 100mg bid, taken orally for one year

Study summary

This study aimed to investigate the efficacy of vitamin B1 in patients with familial adenomatous polyposis, and to determine the inhibitory effect of vitamin B1 on the size and number of colorectal adenomas by administering oral vitamin B1 therapy for 1 year and colonoscopy follow-up every 3 months

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria 1. Patients with a confirmed diagnosis of classical familial adenomatous polyposis (FAP) based on colonoscopy, histopathology, and genetic testing. 2. Aged between 18 and 80 years, with no restriction on gender. 3. No history of total colectomy, with remaining bowel segments available for evaluation. 4. Presence of more than 10 adenomatous polyps in the colon or rectum. 5. Normal liver and kidney function. 6. Willing to participate in vitamin B1 therapy and commit to regular follow-up appointments. Exclusion Criteria 1. Use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect colorectal polyps, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), ω-3 polyunsaturated fatty acids, rapamycin, and curcumin. 2. Use of medications for more than one week in the past three months, or inability to avoid continuous use during the study period, that may affect vitamin B1 absorption, metabolism, or excretion, including aminoglycoside antibiotics, thiazide diuretics, oral contraceptives, antiepileptic drugs, and antituberculosis drugs. 3. Attenuated familial adenomatous polyposis (AFAP). 4. Allergy to vitamin B1. 5. Contraindications to vitamin B1, such as liver or kidney dysfunction, or severe neuropsychiatric disorders. 6. History of total colectomy, with no remaining bowel segments. 7. Pregnant or breastfeeding individuals. 8. Presence of advanced colorectal cancer or metastatic cancer in other locations. 9. Previous radiotherapy, chemotherapy, or tumor immunotherapy. 10. History of alcohol or other substance abuse.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Zhongshan Hospital Shanghai Shanghai Municipality

More Shanghai Zhongshan Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06649825 on ClinicalTrials.gov ↗ ← All trials in China