Single Centre, open label assignment phase II clinical study. To evaluate the effect of oral 200mg Methylene Blue tablets (administered 8x25mg) prior to endoscopy on double stranded DNA breaks in colonic biopsy samples assessed by histone gamma H2AX analysis, compared to control biopsies.
Primary Objective: To evaluate the effect of oral 200 mg Methylene Blue MMX® tablets, (administered as 8 x 25 mg), prior to endoscopy, on double-stranded DNA breaks in colonic biopsy samples assessed by histone γH2AX analysis, compared to control biopsies collected during standard white light colonoscopy without the prior use of Methylene Blue MMX®. Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX® tablets.. To evaluate the staining score for colonoscopy obtained with oral Methylene Blue MMX® tablets . Time to reach the caecum during colonoscopy and withdrawal time from caecum to exit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
10
standard white light colonoscopy
8x25mg methylene blue MMX tablets administered before a colonoscopy
IRCCS Instituto Clinico Humanitas
Rozzano, Italy
Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy
Assay of gamma H2AX histone phosphorylation in biopsy samples collected during colonoscopy.
Time frame: 2 weeks
To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.
Staining quality (SC) observed in each colonic region, in the FAS set (N=10); mean (±SD) is reported for SC. SC is ranked as follows: 0 no staining 1. traces (poor traces in colon mucosa) 2. detectable (at least the 25% of colon mucosa is stained) 3. acceptable (at least the 50% of colon mucosa is stained) 4. good (at least the 75% of colon mucosa is stained) 5. overstained ( the 100% of the colon mucosa is over stained)
Time frame: During the colonoscopy
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