Occult Obscure Gastrointestinal Bleeding

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

Conditions
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Gastrointestinal Bleeding

Intervention / Treatment
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* Dietary Supplement: PG low molecular weight chitosan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CD patients<br>PG low molecular weight chitosan 3 times per day | Dietary Supplement: PG low molecular weight chitosan<br>* The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals<br>* Other names: Low molecular weight polyglucosamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Occult bleeding | Bleeding in feces | Baseline - 1 month - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal discomfort | Measurement through visual analogue scale | Baseline - 1 week - 1 month - 3 months |