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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Patients will be asked to take lactoferrin CRX as already mentioned (blindly).
Patients will be asked to take placebo as already mentioned (blindly).
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
RECRUITINGAbdominal symptoms reduction
The primary outcome measure is the percentage of patients with a reduction of at least the 50% of the symptoms according to the Tursi questionnaire.
Time frame: 4 weeks
Symptom-free remission
The percentage of patients that will achieve symptom-free remission after a 4-week course of lactoferrin CRX vs placebo, according to the Tursi questionnaire.
Time frame: 4 week
36-item short form survey (SF-36)
Evaluation of the quality of life after a 4-week course of lactoferrin CRX vs placebo, according to the 36-item short form survey (SF-36)
Time frame: 4 weeks
Fecal microbiota
Evaluation of fecal microbiota after a 4-week course of lactoferrin CRX vs placebo
Time frame: 4 weeks
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