Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

Trial Title: Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

NCT ID: NCT06649825

Condition: Familial Adenomatous Polyposis (FAP)

Conditions: Official terms:
Colorectal Neoplasms
Nasopharyngeal Neoplasms
Adenomatous Polyposis Coli
Thiamine

Conditions: Keywords:
Familial adenomatous polyposis
thiamin

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Vitamin B1
Description: Vitamin B1 tablets, 100mg bid, taken orally for one year
Arm group label: Vitamin B1

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

Detailed description: We will mark a region with a diameter of no more than 5 cm, containing at least 3 polyps, each with a diameter of 5-15 mm. Continuous video recording will be conducted throughout the colonoscopy procedure to provide baseline reference images of the colorectal polyps. Patients with familial adenomatous polyposis were given 100mg bid dose of vitamin B1 orally for one year, and colonoscopies were followed every 3 months to observe changes in the size and number of polyps in the designated area.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Zhongshan Hospital

Address:
City: Shanghai
Zip: 200032
Country: China

Start date: January 8, 2024

Completion date: December 2025

Lead sponsor:
Agency: Shanghai Zhongshan Hospital
Agency class: Other

Source: Shanghai Zhongshan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06649825