Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03464539
Status:
COMPLETED
Last Update Posted:
2020-04-30
First Post:
2018-02-07
Brief Title:
Occult Obscure Gastrointestinal Bleeding
Sponsor:
Blymum Srl
Organization:
Blymum Srl
Study Overview
Official Title:
Occult Obscure Gastrointestinal Bleeding OGIB in Colonic Diverticulitis Using Polyglucosamine a Registry Study Following a Standard Management Protocol
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
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:
OGIB
Brief Summary:
To test the activity of a polyglucosamine PG together with a Standard Management protocol SM on the occult and obscure gastrointestinal bleeding OGIB and the clinical symptoms in patients suffering from colonic diverticulitis CD
Detailed Description:
The trial was conducted in a single center and subjects were participating to the San Valentino Vascular Screening Project SVVSP Sixty patients with history of colonic diverticulitis CD and occult obscure gastrointestinal bleeding OGIB were recruited All subjects were following a Standard Management SM protocol consisting of diet and lifestyle modifications and were freely choosing to be treated with polyglucosamine PG or to follow the SM only Two groups of 30 cases each were formed and followed for 3 months
Diet was controlled three times baseline and during the first and third month through the Food Intake Assessment FIA which consisted of the weekly analysis of 25 different servings eg fruits vegetables pulses first dish meat processed meat cheese The lifestyle modification consisted of physical exercise 9 MET Metabolic Equivalents -hweek of brisk walking and oral hygiene
The main variable was OGIB that was measured using Hemoccult Sensa Fecal Occult Blood Procedure
Ancillary variables where the hs-CRP high sensitivity C Ractive Protein and the daily gastrointestinal discomfort GID measured thorough a visual analogue scale VAS from 0 to 10
All variables were taken at baseline after one and three months with the exception of GID that was measured also after one week of treatment
Diet was controlled three times baseline and during the first and third month through the Food Intake Assessment FIA which consisted of the weekly analysis of 25 different servings eg fruits vegetables pulses first dish meat processed meat cheese The lifestyle modification consisted of physical exercise 9 MET Metabolic Equivalents -hweek of brisk walking and oral hygiene
The main variable was OGIB that was measured using Hemoccult Sensa Fecal Occult Blood Procedure
Ancillary variables where the hs-CRP high sensitivity C Ractive Protein and the daily gastrointestinal discomfort GID measured thorough a visual analogue scale VAS from 0 to 10
All variables were taken at baseline after one and three months with the exception of GID that was measured also after one week of treatment
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