Familial Adenomatous PolyposisPhase 2NCT03061591
Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis.
A Phase 2 study testing Wholistic Turmeric capsules in people with Familial Adenomatous Polyposis and FAP, run by Tel-Aviv Sourasky Medical Center.
Trial summary
A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Familial Adenomatous Polyposis, FAP, FAP Gene Mutation
- What is being tested?
- Wholistic Turmeric capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Apr 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An established clinical diagnosis of Familial Polyposis based on accepted clinical/ endoscopic and an identified APC or MUTYH mutation
- Age 18-70 years.
- Willing and able to give written consent.
- At least 5 polyps, 2mm or lrager, with at least one larger then 4mm but not more then 20mm.
- Colonic polyp burden that can be estimated by either counting or photographing(photo or video).
Who cannot join
- Pregnant or nursing women.
- Stable does of any COX inhibitor drugs for more than 3 months prior to study entry,.
- Concomitant severe or uncontrolled cardiovascular, hepatic, renal or metabolic disease.
- Known allergy to curcumin.
- Anticipated surgery within 6 months
- Diagnosed polyps of high grade dysplasia or of adenocarcinomas in the GI on screening colonoscopy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Wholistic Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis A Randomized, Double Blinded, Placebo Controlled Study
A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or placebo for six months.
Read the detailed description
Fourty individuals with identified APC mutation or MUTYH mutation that result in a phenotype of multiple colonic adenomas with or without duodenal adenomas will be included in the study. Participants will be allocated in a 1:1 ratio to receive either wholistic Turmeric capsules (Pukka herbs) or placebo for 6 months.
Participants will be assessed by a gastroenterologist 4-8 weeks after initiation, and at termination/conclusion visit at 6 months.
Blood, stool and urine samples will be collected at baseline, after 4-8 weeks and at 6 months just before final colonoscopy.
Serum samples will be used for testing complete blood count, liver function test, C-reactive protein (CRP) Various cytokines and small molecule measurements. Stool samples will be evaluated for microbiome composition.
Curcumin and curcuminoid levels will be measured in tissue serum, stool and urine will be measured in a subsample of patients.
Colonoscopy will be performed at study entry with removal of all polyps larger than 20mm, count and precise size measurement of polyps by a standard forceps, throughout the colon and in defined segments. Retained polyps will be counted and measured with an open forceps placed near the polyp to determine size. A full video and photos of the procedure will be taken. In cases with multiple polyps that cannot be counted or properly evaluated the PI will decide if a defined area like the rectum could be evaluated and will define it in terms of distance from the anus. In this case the video of the procedure will be evaluated by two separate gastroeneterologists blinded to treatment arm.
Frozen samples from normal mucosa will be taken at study entry. Samples from polyps will be taken preferably in cases with multiple polyp in order not to interrupt measurments.
Upper endoscopy only in patients with known duodenal adenomas will also be performed at study entry with as above evaluation. Sample from polyps and normal mucosa will be taken as above. A full video and photos of the upper endoscopy will be recorded as well.
A 2nd colonoscopy +/- gastroscopy will be performed at 6 months when all polyps will be counted and pictured by video and photography. Size determination in a similar way as above, throughout the colon or in the defined area as was decided at baseline colonoscopy.
Frozen samples from polyps and normal mucosa will be taken and polypoectomy will be performed upon the decision of the endoscopist in both lower and upper endoscopies.
Frozen tissue specimen will be used for H\&E, various proliferation and apoptosis staining like KI67.
Tissue, blood, urine and stool samples will be frozen and sent for analysis.
Inclusion/screening visit will include:
- Intake of patient medical history.
- Exact documentation of identified genetic mutation per genetic consultation
- Case report form (CRF).
- Blood test including complete blood count, liver function test, C-reactive protein (CRP) and sera for subsequent cytokine analysis.
- Urine and Stool collection .
- Basline colonoscopy and/or upper endoscopy as detiled above with tissue collection and tattoo of tissue sampled.
Mid-term visit at 4-8 weeks will include:
- Case report form (CRF).
- Collection of Blood, urine and stool specimens.
Termination/conclusion visit will include:
- Case report form (CRF).
- Collection of blood, urine, stool specimens
- Colonoscopy and upper endoscopy as described above with tissue collection of same tissue identified by tattoo.
- Conditions
- Familial Adenomatous Polyposis, FAP, FAP Gene Mutation
- Being tested
- Wholistic Turmeric capsules, Placebo
- Keywords
- Turmeric, Curcumin, colorectal polyps, colorectal neoplasia, mutyh mutation, apc mutation
- 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.
Wholistic Turmeric capsulesDietary supplement
Oral capsules of wholistic Turmeric capsules (Pukka herbs) curcumin (each capsule 0.5100 m gr curcumin) for a total of 4 gr/d divided twice daily.
PlaceboOther
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Wholistic Turmeric capsules | Active comparator | Oral capsules of wholistic Turmeric capsules (Pukka herbs) (each capsule 100 mg curcumin) divided twice daily, or an identical placebo in 2 divided doses daily all taken before meals.
Pukka's Wholistic Turmeric Receives: Dietary Supplement: Wholistic Turmeric capsules |
| Placebo | Placebo comparator | Identical placebo capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of polyps
Measured: 6 months
Size of polyps
Measured: 6 months
Secondary outcomes (7)
Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
Measured: 6 months
Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
Measured: 6 months
Colonic microbiome composition, after curcumin therapy.
Measured: 6 months
Duodenal adenoma number.
Measured: 6 months
Duodenal adenoma size.
Measured: 6 months
Curcumin and curcuminoid levels in blood.
Measured: 6 months
Curcumin and curcuminoid levels in urine.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startApr 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Familial Adenomatous PolyposisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 6 months of Curcumin vs. placebo treatment outcomes will be compared.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Revital Kariv, MD, Principal investigator, Tel Aviv SMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061591
- Sponsor's protocol ID
- TASMC-15-RK-0601-CTIL
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cruz-Correa M, Shoskes DA, Sanchez P, Zhao R, Hylind LM, Wexner SD, Giardiello FM. Combination treatment with curcumin and quercetin of adenomas in familial adenomatous polyposis. Clin Gastroenterol Hepatol. 2006 Aug;4(8):1035-8. doi: 10.1016/j.cgh.2006.03.020. Epub 2006 Jun 6.
PubMed 16757216Perkins S, Verschoyle RD, Hill K, Parveen I, Threadgill MD, Sharma RA, Williams ML, Steward WP, Gescher AJ. Chemopreventive efficacy and pharmacokinetics of curcumin in the min/+ mouse, a model of familial adenomatous polyposis. Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):535-40.
PubMed 12050094Pettan-Brewer C, Morton J, Mangalindan R, Ladiges W. Curcumin suppresses intestinal polyps in APC Min mice fed a high fat diet. Pathobiol Aging Age Relat Dis. 2011;1. doi: 10.3402/pba.v1i0.7013. Epub 2011 Jun 1.
PubMed 22953026
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wholistic Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis A Randomized, Double Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT03061591
- Acronym / sponsor ID
- TASMC-15-RK-0601-CTIL
- Conditions
- Familial Adenomatous Polyposis, FAP, FAP Gene Mutation
- Keywords
- Turmeric, Curcumin, colorectal polyps, colorectal neoplasia, mutyh mutation, apc mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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.
A Phase 2, randomized, double blind, placebo controlled trial for the effectivness of wholistic turmeric supplementation on polyp burden mong patients with Familial Adenomatouse Polyposis (FAP). Fourty Patients will be randomly assigned in a 1:1 ratio to recieve treatment with 8 capsuls (2*4 capsuls/day) of wholistic Turmeric capsules (Pukka herbs) or placebo for six months.
Detailed description
Fourty individuals with identified APC mutation or MUTYH mutation that result in a phenotype of multiple colonic adenomas with or without duodenal adenomas will be included in the study. Participants will be allocated in a 1:1 ratio to receive either wholistic Turmeric capsules (Pukka herbs) or placebo for 6 months.
Participants will be assessed by a gastroenterologist 4-8 weeks after initiation, and at termination/conclusion visit at 6 months.
Blood, stool and urine samples will be collected at baseline, after 4-8 weeks and at 6 months just before final colonoscopy.
Serum samples will be used for testing complete blood count, liver function test, C-reactive protein (CRP) Various cytokines and small molecule measurements. Stool samples will be evaluated for microbiome composition.
Curcumin and curcuminoid levels will be measured in tissue serum, stool and urine will be measured in a subsample of patients.
Colonoscopy will be performed at study entry with removal of all polyps larger than 20mm, count and precise size measurement of polyps by a standard forceps, throughout the colon and in defined segments. Retained polyps will be counted and measured with an open forceps placed near the polyp to determine size. A full video and photos of the procedure will be taken. In cases with multiple polyps that cannot be counted or properly evaluated the PI will decide if a defined area like the rectum could be evaluated and will define it in terms of distance from the anus. In this case the video of the procedure will be evaluated by two separate gastroeneterologists blinded to treatment arm.
Frozen samples from normal mucosa will be taken at study entry. Samples from polyps will be taken preferably in cases with multiple polyp in order not to interrupt measurments.
Upper endoscopy only in patients with known duodenal adenomas will also be performed at study entry with as above evaluation. Sample from polyps and normal mucosa will be taken as above. A full video and photos of the upper endoscopy will be recorded as well.
A 2nd colonoscopy +/- gastroscopy will be performed at 6 months when all polyps will be counted and pictured by video and photography. Size determination in a similar way as above, throughout the colon or in the defined area as was decided at baseline colonoscopy.
Frozen samples from polyps and normal mucosa will be taken and polypoectomy will be performed upon the decision of the endoscopist in both lower and upper endoscopies.
Frozen tissue specimen will be used for H\&E, various proliferation and apoptosis staining like KI67.
Tissue, blood, urine and stool samples will be frozen and sent for analysis.
Inclusion/screening visit will include:
- Intake of patient medical history.
- Exact documentation of identified genetic mutation per genetic consultation
- Case report form (CRF).
- Blood test including complete blood count, liver function test, C-reactive protein (CRP) and sera for subsequent cytokine analysis.
- Urine and Stool collection .
- Basline colonoscopy and/or upper endoscopy as detiled above with tissue collection and tattoo of tissue sampled.
Mid-term visit at 4-8 weeks will include:
- Case report form (CRF).
- Collection of Blood, urine and stool specimens.
Termination/conclusion visit will include:
- Case report form (CRF).
- Collection of blood, urine, stool specimens
- Colonoscopy and upper endoscopy as described above with tissue collection of same tissue identified by tattoo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 6 months of Curcumin vs. placebo treatment outcomes will be compared.
| Arm | Type | Receives |
|---|---|---|
| Wholistic Turmeric capsules | Active comparator | Dietary Supplement: Wholistic Turmeric capsulesOral capsules of wholistic Turmeric capsules (Pukka herbs) (each capsule 100 mg curcumin) divided twice daily, or an identical placebo in 2 divided doses daily all taken before meals. Pukka's Wholistic Turmeric |
| Placebo | Placebo comparator | Other: PlaceboIdentical placebo capsules |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An established clinical diagnosis of Familial Polyposis based on accepted clinical/ endoscopic and an identified APC or MUTYH mutation
- Age 18-70 years.
- Willing and able to give written consent.
- At least 5 polyps, 2mm or lrager, with at least one larger then 4mm but not more then 20mm.
- Colonic polyp burden that can be estimated by either counting or photographing(photo or video).
Key exclusion criteria (6 listed)
- Pregnant or nursing women.
- Stable does of any COX inhibitor drugs for more than 3 months prior to study entry,.
- Concomitant severe or uncontrolled cardiovascular, hepatic, renal or metabolic disease.
- Known allergy to curcumin.
- Anticipated surgery within 6 months
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 |
|---|---|---|
| Wholistic Turmeric capsulesOral capsules of wholistic Turmeric capsules (Pukka herbs) curcumin (each capsule 0.5100 m gr curcumin) for a total of 4 gr/d divided twice daily. | Dietary supplement | Wholistic Turmeric capsules |
| PlaceboPlacebo capsules | Other | Placebo |
Primary outcome
Number of polyps
Time frame: 6 months
Size of polyps
Time frame: 6 months
7 secondary outcomes
Histological apoptosis assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
Time frame: 6 months
Histological proliferation assays in frozen polyps and normal tissue (such as KI67, caspase 3 activity and COX-2 expression).
Time frame: 6 months
Colonic microbiome composition, after curcumin therapy.
Time frame: 6 months
Duodenal adenoma number.
Time frame: 6 months
Duodenal adenoma size.
Time frame: 6 months
Curcumin and curcuminoid levels in blood.
Time frame: 6 months
Curcumin and curcuminoid levels in urine.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 16757216Cruz-Correa M, Shoskes DA, Sanchez P, Zhao R, Hylind LM, Wexner SD, Giardiello FM. Combination treatment with curcumin and quercetin of adenomas in familial adenomatous polyposis. Clin Gastroenterol Hepatol. 2006 Aug;4(8):1035-8. doi: 10.1016/j.cgh.2006.03.020. Epub 2006 Jun 6.
- Background: PubMed 12050094Perkins S, Verschoyle RD, Hill K, Parveen I, Threadgill MD, Sharma RA, Williams ML, Steward WP, Gescher AJ. Chemopreventive efficacy and pharmacokinetics of curcumin in the min/+ mouse, a model of familial adenomatous polyposis. Cancer Epidemiol Biomarkers Prev. 2002 Jun;11(6):535-40.
- Background: PubMed 22953026Pettan-Brewer C, Morton J, Mangalindan R, Ladiges W. Curcumin suppresses intestinal polyps in APC Min mice fed a high fat diet. Pathobiol Aging Age Relat Dis. 2011;1. doi: 10.3402/pba.v1i0.7013. Epub 2011 Jun 1.
- Individual participant dataSharing planned: No
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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.
Revital Kariv, MD principal investigator
Tel Aviv SMC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Wholistic Turmeric capsules in people with Familial Adenomatous Polyposis and FAP, run by Tel-Aviv Sourasky Medical Center.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naomi Fliss, MSc (97236974458, naomifl@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of polyps (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061591, which also lists 3 linked publications.
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 23 Feb 2017.