NCT03464539

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
Last Updated

April 30, 2020

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

February 7, 2018

Last Update Submit

April 29, 2020

Conditions

Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

  • Change of Occult bleeding

    Bleeding in feces

    Baseline - 1 month - 3 months

Secondary Outcomes (1)

  • Gastrointestinal discomfort

    Baseline - 1 week - 1 month - 3 months

Study Arms (1)

CD patients

OTHER

PG low molecular weight chitosan 3 times per day

Dietary Supplement: PG low molecular weight chitosan

Interventions

PG low molecular weight chitosanDIETARY_SUPPLEMENT

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

Also known as: Low molecular weight polyglucosamine
CD patients

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spoltore - Pescara

Pescara, Italy

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gianni Belcaro, MD

    University of Chieti

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 14, 2018

Study Start

February 1, 2017

Primary Completion

May 15, 2017

Study Completion

June 15, 2017

Last Updated

April 30, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)