Gastrointestinal Bleeding Clinical Trial
Official title:
Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
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).
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
(e,g fruits, vegetables, pulses, first dish, meat, processed meat, cheese). The lifestyle
modification consisted of physical exercise (9 MET (Metabolic Equivalents) -h/week 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.
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