Diverticular Disease Clinical Trial
Official title:
Symptomatic Uncomplicated Diverticular Disease: a lactofErriN piLot studY
Diverticular disease is a chronic pathology, characterized by recurrent abdominal symptoms
and a high social impact, with a high prevalence in developed countries, especially among the
elderly. Diverticula are thought to develop from age-related degeneration of the mucosal wall
and segmental increases in colon pressure resulting in bulging at points of weakness,
typically at the insertion of the vasa recta. Classification of diverticular disease is
largely based on symptoms: it begins with the development of diverticulosis, to asymptomatic
disease, to symptomatic uncomplicated diverticular disease (SUDD) and finally to complicated
disease when patients develop abscesses, phlegmon, bleeding, fistula and sepsis.
Approximately the 20% of the patients with diverticular disease has symptoms, such as
abdominal pain, fever and altered bowel movement and, in the last decades, a significant
increase of the incidence of complications related to the disease has been recorded, in
particular of intestinal perforation.
Lactoferrin (Lf) is a glycoprotein present in several secretory liquids - i.e. milk, saliva
and tears - with antimicrobial properties that it exert to seizing iron, thus preventing the
use by the pathogens, or altering their plasma membrane through its highly cationic charge.
The investigators hypothesize that the antimicrobial and immunoregulatory characteristics of
the Lf can be used to maintain an adequate homeostasis of the intestinal mucosa in patients
with SUDD resulting in an improvement of both symptoms and quality of life.
The investigators will verify whether a 4-week treatment with lactoferrin CRX is able to reduce SUDD-related symptoms, thus improving patient's quality of life. Symptoms will be assessed with the questionnaire by Tursi et al. ;
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