Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03061591
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2017-02-14
Brief Title:
Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Fourty Patients will be randomly assigned in a 11 ratio to recieve treatment with 8 capsuls 24 capsulsday 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 11 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 terminationconclusion 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 HE various proliferation and apoptosis staining like KI67
Tissue blood urine and stool samples will be frozen and sent for analysis
Inclusionscreening visit will include
1 Intake of patient medical history
2 Exact documentation of identified genetic mutation per genetic consultation
3 Case report form CRF
4 Blood test including complete blood count liver function test C-reactive protein CRP and sera for subsequent cytokine analysis
5 Urine and Stool collection
6 Basline colonoscopy andor upper endoscopy as detiled above with tissue collection and tattoo of tissue sampled
Mid-term visit at 4-8 weeks will include
1 Case report form CRF
2 Collection of Blood urine and stool specimens
Terminationconclusion visit will include
1 Case report form CRF
2 Collection of blood urine stool specimens
3 Colonoscopy and upper endoscopy as described above with tissue collection of same tissue identified by tattoo
Participants will be assessed by a gastroenterologist 4-8 weeks after initiation and at terminationconclusion 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 HE various proliferation and apoptosis staining like KI67
Tissue blood urine and stool samples will be frozen and sent for analysis
Inclusionscreening visit will include
1 Intake of patient medical history
2 Exact documentation of identified genetic mutation per genetic consultation
3 Case report form CRF
4 Blood test including complete blood count liver function test C-reactive protein CRP and sera for subsequent cytokine analysis
5 Urine and Stool collection
6 Basline colonoscopy andor upper endoscopy as detiled above with tissue collection and tattoo of tissue sampled
Mid-term visit at 4-8 weeks will include
1 Case report form CRF
2 Collection of Blood urine and stool specimens
Terminationconclusion visit will include
1 Case report form CRF
2 Collection of blood urine stool specimens
3 Colonoscopy and upper endoscopy as described above with tissue collection of same tissue identified by tattoo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None