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Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

Not Applicable
Conditions
Familial Adenomatous Polyposis (FAP)
Interventions
Registration Number
NCT06649825
Lead Sponsor
Shanghai Zhongshan Hospital
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.

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
10
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Vitamin B1Vitamin B1-
Primary Outcome Measures
NameTimeMethod
Sum of polyp diameters in the delineated area3 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.

Secondary Outcome Measures
NameTimeMethod
The number of polyps in the delineated area3 months

The number of polyps was assessed by two independent endoscopists, and disputes were decided by a third endoscopist

Levels of vitamin B1-associated metabolites, including TMP, TPP, TTP, and free thiamine, in blood and urine samples and in polyps outside the delineated area3 months

The content of vitamin B1 related metabolites was determined by liquid chromatography-tandem mass spectrometry

Trial Locations

Locations (1)

Shanghai Zhongshan Hospital

🇨🇳

Shanghai, Shanghai, China

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