Evaluation of the Efficacy of Vitamin B1 in Patients With Familial Adenomatous Polyposis: An Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Sum of polyp diameters in the delineated area
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of classical familial adenomatous polyposis (FAP) based on colonoscopy, histopathology, and genetic testing.
- •Aged between 18 and 80 years, with no restriction on gender.
- •No history of total colectomy, with remaining bowel segments available for evaluation.
- •Presence of more than 10 adenomatous polyps in the colon or rectum.
- •Normal liver and kidney function.
- •Willing to participate in vitamin B1 therapy and commit to regular follow-up appointments.
排除标准
- •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.
- •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.
- •Attenuated familial adenomatous polyposis (AFAP).
- •Allergy to vitamin B
- •Contraindications to vitamin B1, such as liver or kidney dysfunction, or severe neuropsychiatric disorders.
- •History of total colectomy, with no remaining bowel segments.
- •Pregnant or breastfeeding individuals.
- •Presence of advanced colorectal cancer or metastatic cancer in other locations.
- •Previous radiotherapy, chemotherapy, or tumor immunotherapy.
- •History of alcohol or other substance abuse.
研究组 & 干预措施
Vitamin B1
干预措施: Vitamin B1 (Drug)
结局指标
主要结局
Sum of polyp diameters in the delineated area
时间窗: 3 months
The diameter of each polyp was assessed by two independent endoscopists and the average of two diameters perpendicular to each other was reported. The diameter of the polyp was determined with reference to the titanium clip, blood vessels and scar in the visual field.
次要结局
- The number of polyps in the delineated area(3 months)
- Levels of vitamin B1-associated metabolites, including TMP, TPP, TTP, and free thiamine, in blood and urine samples and in polyps outside the delineated area(3 months)