Occult Obscure Gastrointestinal Bleeding

NCT ID: NCT03464539

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-06-15

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.

Conditions

Gastrointestinal Bleeding

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CD patients

PG low molecular weight chitosan 3 times per day

Group Type: OTHER

PG low molecular weight chitosan

Intervention Type: DIETARY_SUPPLEMENT

The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals

Interventions

PG low molecular weight chitosan

The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Low molecular weight polyglucosamine

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Blymum Srl

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianni Belcaro, MD

Role: STUDY_DIRECTOR

University of Chieti

Locations

Spoltore - Pescara

Pescara, , Italy

Countries

Italy

Other Identifiers

20180206_UC

Identifier Type: -

Identifier Source: org_study_id