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Enrolling by invitation NCT06649825

Efficacy of Vitamin B1 in Familial Adenomatous Polyposis Patients.

No phase Interventional Familial Adenomatous Polyposis (FAP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin B1.
Who it may be relevant to
Registry conditions: Familial Adenomatous Polyposis (FAP). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Efficacy of Vitamin B1 in Patients With Familial Adenomatous Polyposis: An Exploratory Study

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

Detailed 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.

Interventions

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

Primary outcome measures

  • Sum of polyp diameters in the delineated area [Time frame: 3 months]
Secondary outcome measures (2)
  • The number of polyps in the delineated area [Time frame: 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 [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 B1.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shanghai Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT06649825 · ShanghaiZhongshanEndoscopy2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗