Completed

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

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What is being tested

PG low molecular weight chitosan

Dietary Supplement
Who is being recruted

Digestive System Diseases+3

+ Gastrointestinal Diseases

+ Hemorrhage

From 55 to 65 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: February 2017
See protocol details

Summary

Principal SponsorBlymum Srl
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleOccult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
NCT03464539
Principal SponsorBlymum Srl
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastrointestinal DiseasesHemorrhageGastrointestinal HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
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.

8 exclusion criteria prevent from participating
Subjects with Class DICA > 3.

Therapy with mesalazine antibiotics and probiotics.

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

Alcoholism.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

PG low molecular weight chitosan 3 times per day

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Spoltore - Pescara

Pescara, ItalyOpen Spoltore - Pescara in Google Maps
CompletedOne Study Center
OGIB | Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol | PatLynk