Gastrointestinal BleedingOGIBNCT03464539
Occult Obscure Gastrointestinal Bleeding
A study testing PG low molecular weight chitosan in people with Gastrointestinal Bleeding, run by Blymum Srl at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Gastrointestinal Bleeding
- What is being tested?
- PG low molecular weight chitosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2017to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
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).
Read the 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.
- Conditions
- Gastrointestinal Bleeding
- Being tested
- PG low molecular weight chitosan
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG low molecular weight chitosanDietary supplement
Also called Low molecular weight polyglucosamine
The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals
| Study group | Role | What they receive |
|---|---|---|
| CD patients | Other | PG low molecular weight chitosan 3 times per day Receives: Dietary Supplement: PG low molecular weight chitosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Occult bleeding
Bleeding in feces
Measured: Baseline - 1 month - 3 months
Secondary outcomes (1)
Gastrointestinal discomfort
Measurement through visual analogue scale
Measured: Baseline - 1 week - 1 month - 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Feb 2017
- Primary completion15 May 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blymum Srl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianni Belcaro, MD, Study director, University of Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464539
- Sponsor's protocol ID
- 20180206_UC
- Acronym
- OGIB
- Status last verified
- Feb 2018
- First submitted
- 7 Feb 2018
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
- ClinicalTrials.gov ID
- NCT03464539
- Acronym / sponsor ID
- OGIB / 20180206_UC
- Conditions
- Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Blymum SrlUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD patients | Other | Dietary Supplement: PG low molecular weight chitosanPG low molecular weight chitosan 3 times per day |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Subjects with Class DICA > 3.
- Therapy with mesalazine antibiotics and probiotics.
- Cancer of any type (a part from benign polyposis),
- Alcoholism.
- Parkinsonism.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG low molecular weight chitosanAlso: Low molecular weight polyglucosamineThe product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals | Dietary supplement | CD patients |
Primary outcome
Change of Occult bleeding
Time frame: Baseline - 1 month - 3 months
Bleeding in feces
1 secondary outcome
Gastrointestinal discomfort
Time frame: Baseline - 1 week - 1 month - 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianni Belcaro, MD study director
University of Chieti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PG low molecular weight chitosan in people with Gastrointestinal Bleeding, run by Blymum Srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Occult bleeding (time frame: Baseline - 1 month - 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.