Could a common vitamin tame a rare gut disease?
NCT ID NCT06649825
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking vitamin B1 tablets for a year can reduce the size and number of colon polyps in people with familial adenomatous polyposis (FAP), a genetic condition that raises colon cancer risk. Ten adults with FAP who still have their colon will take vitamin B1 twice daily and get colonoscopies every three months to track changes. It's a small, early-stage trial exploring a potential new use for a safe, inexpensive vitamin.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin B1 (thiamine) tablets
- What this could lead to
- If it works, this could point toward a simple, low-cost way to reduce polyp growth in people with familial adenomatous polyposis, potentially lowering their cancer risk.
- What could go wrong
- This is a very small, early exploratory study with only 10 people, so results may not apply broadly. It's not yet known if vitamin B1 will have any real effect on polyps.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental drug stop polyps from coming back in a rare inherited condition?
- Which scope method spots precancerous polyps best in FAP pouches? a head-to-head trial aims to find out.
- Rapamycin formulation offers hope for rare polyp disorder
- New national registry aims to improve care for rare genetic polyposis syndromes
- New surgical approach may improve outcomes for bowel disease patients
- New drug eRapa could slow polyps in inherited colon cancer condition