Occult Obscure Gastrointestinal Bleeding (OGIB)
Primary Purpose
Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PG low molecular weight chitosan
Sponsored by
About this trial
This is an interventional prevention trial for Gastrointestinal Bleeding
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.
Sites / Locations
- Spoltore - Pescara
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CD patients
Arm Description
PG low molecular weight chitosan 3 times per day
Outcomes
Primary Outcome Measures
Change of Occult bleeding
Bleeding in feces
Secondary Outcome Measures
Gastrointestinal discomfort
Measurement through visual analogue scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03464539
Brief Title
Occult Obscure Gastrointestinal Bleeding
Acronym
OGIB
Official Title
Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
June 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blymum Srl
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD patients
Arm Type
Other
Arm Description
PG low molecular weight chitosan 3 times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
PG low molecular weight chitosan
Other Intervention Name(s)
Low molecular weight polyglucosamine
Intervention Description
The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals
Primary Outcome Measure Information:
Title
Change of Occult bleeding
Description
Bleeding in feces
Time Frame
Baseline - 1 month - 3 months
Secondary Outcome Measure Information:
Title
Gastrointestinal discomfort
Description
Measurement through visual analogue scale
Time Frame
Baseline - 1 week - 1 month - 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianni Belcaro, MD
Organizational Affiliation
University of Chieti
Official's Role
Study Director
Facility Information:
Facility Name
Spoltore - Pescara
City
Pescara
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Occult Obscure Gastrointestinal Bleeding
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