Spoltore - Pescara
Pescara, Italy
NCT Number: NCT03464539
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).
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Notify Me55 year–65 year
All sexes
Interventional
Not applicable
Pescara, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals
Other names: Low molecular weight polyglucosamine
Time frame: Baseline - 1 month - 3 months
Bleeding in feces
Time frame: Baseline - 1 week - 1 month - 3 months
Measurement through visual analogue scale
Blymum Srl
Other
Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
Acronym: OGIB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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