NCT03464539

Occult Obscure Gastrointestinal Bleeding

Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Blymum Srl · Academic / Other
• Sex: All
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Gastrointestinal Bleeding

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PG low molecular weight chitosan	The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-05-15
• Completion: 2017-06-15
• First posted: 2018-03-14
• Last updated: 2020-04-30

Locations

1 site across 1 country: Italy