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OpenTrials
Completed

NCT Number: NCT03464539

Occult Obscure Gastrointestinal Bleeding

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).

Completed

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Key information

Age range

55 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spoltore - Pescara

Pescara, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PG low molecular weight chitosan

Dietary Supplement

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

Other names: Low molecular weight polyglucosamine

Primary outcomes

  1. Change of Occult bleeding

    Time frame: Baseline - 1 month - 3 months

    Bleeding in feces

Secondary outcomes

  1. Gastrointestinal discomfort

    Time frame: Baseline - 1 week - 1 month - 3 months

    Measurement through visual analogue scale

Sponsors and collaborators

Lead sponsor

Blymum Srl

Other

Registry information

Official study title

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

Acronym: OGIB

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 14, 2018
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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