Gastrointestinal Bleeding
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPG low molecular weight chitosan
The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals
Sponsors
Blymum Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Occult bleeding | Baseline - 1 month - 3 months | Bleeding in feces |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal discomfort | Baseline - 1 week - 1 month - 3 months | Measurement through visual analogue scale |
Countries
Italy
Outcome results
None listed