Status:

COMPLETED

Occult Obscure Gastrointestinal Bleeding

Lead Sponsor:

Blymum Srl

Conditions:

Gastrointestinal Bleeding

Eligibility:

All Genders

55-65 years

Phase:

NA

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 suffer...

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 occul...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 15 2017

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT03464539

Start Date

February 1 2017

End Date

June 15 2017

Last Update

April 30 2020

Active Locations (1)

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Spoltore - Pescara

Pescara, Italy