Familial Adenomatous PolyposisPhase 2NCT00248053
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis Patients
A Phase 2 study testing curcumin in people with Familial Adenomatous Polyposis, run by Johns Hopkins University.
Trial summary
The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Familial Adenomatous Polyposis
- What is being tested?
- curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Familial adenomatous polyposis
- 18 years of age or older
- 5 or more adenomas of colorectum or ileum
Who cannot join
- Female patient of child bearing age not on effective birth control pills
- Pregnant women
- White blood cell (WBC) count less than 4000
- Platelets (Plts) less than 100,000
- Blood urea nitrogen (BUN) greater than 25
- Creatine greater than 1.5
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- Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
- Malignancy
- Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
- Patient on warfarin or anti-platelet drugs
About this study
Official title: Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.
- Conditions
- Familial Adenomatous Polyposis
- Being tested
- curcumin
- Keywords
- Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch
- Medical subject headings
- Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDrug
curcumin 500 mg by mouth, three times a day for 9 months
| Study group | Role | What they receive |
|---|---|---|
| Lower GI | Other | Not described Receives: Drug: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
polyp number and size
Measured: one year
Secondary outcomes (1)
side effects and medication compliance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2008
Why it stopped: Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francis M. Giardiello, Johns Hopkins University
- Investigators
- Francis M Giardiello, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248053
- Sponsor's protocol ID
- 05-04-12-04
- Status last verified
- Sep 2012
- First submitted
- 1 Nov 2005
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
- ClinicalTrials.gov ID
- NCT00248053
- Acronym / sponsor ID
- 05-04-12-04
- Conditions
- Familial Adenomatous Polyposis
- Keywords
- Familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subsequent data generated by our collaborators have shown efficacy with curcumin and quercetin in 5 patients in a non placebo controlled trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jun 2008 (actual)
- First posted
- 3 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower GI | Other | Drug: curcumin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Familial adenomatous polyposis
- 18 years of age or older
- 5 or more adenomas of colorectum or ileum
Key exclusion criteria (10 listed)
- Female patient of child bearing age not on effective birth control pills
- Pregnant women
- White blood cell (WBC) count less than 4000
- Platelets (Plts) less than 100,000
- Blood urea nitrogen (BUN) greater than 25
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcumincurcumin 500 mg by mouth, three times a day for 9 months | Drug | Lower GI |
Primary outcome
polyp number and size
Time frame: one year
1 secondary outcome
side effects and medication compliance
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis M Giardiello, M.D. principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing curcumin in people with Familial Adenomatous Polyposis, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polyp number and size (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.