Occult Obscure Gastrointestinal Bleeding (OGIB)

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).

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Bleeding
• Intervention / Treatment: Dietary supplement: PG low molecular weight chitosan

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pescara, Italy
    • Spoltore - Pescara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CD patients; PG low molecular weight chitosan 3 times per day	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; Other Names: Low molecular weight polyglucosamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Occult bleeding	Bleeding in feces	Baseline - 1 month - 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal discomfort	Measurement through visual analogue scale	Baseline - 1 week - 1 month - 3 months

Collaborators and Investigators

• Sponsor: Blymum Srl
• Investigators: Study Director: Gianni Belcaro, MD, University of Chieti

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): May 15, 2017
• Study Completion (Actual): June 15, 2017

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hemostatics; Coagulants; Chelating Agents; Sequestering Agents; Chitosan
• Other Study ID Numbers: 20180206_UC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No