Occult Obscure Gastrointestinal Bleeding

Gastrointestinal Bleeding Clinical Trial

— OGIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464539
• Other study ID #: 20180206_UC
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: June 15, 2017

Study information

• Verified date: February 2018
• Source: Blymum Srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects aged between 55 to 65 years (males and females).

• CD diagnosis.

• DICA (Diverticular Inflammation and Complication Assessment) class DICA 2 or DICA 3.

• OGIB positive to Hemoccult Sensa Fecal Occult Blood Procedure.

Exclusion Criteria:

• Subjects with Class DICA > 3.

• Therapy with mesalazine antibiotics and probiotics.

• Cancer of any type (a part from benign polyposis),

• Alcoholism.

• Parkinsonism.

• Alzheimer's Disease.

• Severe depression.

• Drug addiction.

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Italy	Spoltore - Pescara	Pescara

Sponsors (1)

Lead Sponsor	Collaborator
Blymum Srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Occult bleeding	Bleeding in feces	Baseline - 1 month - 3 months
Secondary	Gastrointestinal discomfort	Measurement through visual analogue scale	Baseline - 1 week - 1 month - 3 months