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By invitation only Not applicable NCT06649825

Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

No applicable phase (e.g. observational)
Conditions: Familial Adenomatous Polyposis (FAP)

Sponsor: Shanghai Zhongshan Hospital

trial.available_in: БГ
Overview
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
Description
The investigators 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.
Who can participate
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.
Interventions
Vitamin B1
DRUG
Locations 1
China (1)
Shanghai Zhongshan Hospital
Shanghai , Shanghai Municipality
Technical details
Status
By invitation only
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
08.01.2024
Completion date
01.12.2028
Registry ID
NCT06649825
Source
clinicaltrials.gov
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