NCT03490279

Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease

Symptomatic Uncomplicated Diverticular Disease: a lactofErriN piLot studY

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diverticular Disease
• Symptomatic Uncomplicated Diverticular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactoferrin CRX	Patients will be asked to take lactoferrin CRX as already mentioned (blindly).
OTHER	Placebo	Patients will be asked to take placebo as already mentioned (blindly).

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-05-02
• Completion: 2019-11-02
• First posted: 2018-04-06
• Last updated: 2018-08-10

Locations

1 site across 1 country: Italy