Clinical Trial: Turmeric Supplementation on Polyp Number and Size in Patients With Familial Adenomatous Polyposis.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 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 Summary:

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 tak
Sponsor: Tel-Aviv Sourasky Medical Center

Current Primary Outcome:

  • Number of polyps [ Time Frame: 6 months ]
  • Size of polyps [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Tel-Aviv Sourasky Medical Center

Dates:
Date Received: February 14, 2017
Date Started: April 2017
Date Completion: April 2020
Last Updated: February 19, 2017
Last Verified: February 2017