Occult Obscure Gastrointestinal Bleeding

Not Applicable

Completed

• Conditions: Gastrointestinal Bleeding
• Interventions: Dietary Supplement: PG low molecular weight chitosan

• Registration Number: NCT03464539
• Lead Sponsor: Blymum Srl

Brief 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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-05-15
• Study Completion: 2017-06-15
• Status Verified: 2018-02
• Study First Submitted: 2018-02-07
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-14
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD patients	PG low molecular weight chitosan	PG low molecular weight chitosan 3 times per day

Primary Outcome Measures

Name	Time	Method
Change of Occult bleeding	Baseline - 1 month - 3 months	Bleeding in feces

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal discomfort	Baseline - 1 week - 1 month - 3 months	Measurement through visual analogue scale

Trial Locations

Locations (1)

Spoltore - Pescara; 🇮🇹 Pescara, Italy