Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

NCT ID: NCT06649825

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Familial Adenomatous Polyposis (FAP)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin B1

Group Type: EXPERIMENTAL

Vitamin B1

Intervention Type: DRUG

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

Interventions

Vitamin B1

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pinghong Zhou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ShanghaiZhongshanEndoscopy2

Identifier Type: -

Identifier Source: org_study_id