Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease (SUDDENLY)

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.

Study Overview

• Status: Unknown
• Conditions: Diverticular Disease; Symptomatic Uncomplicated Diverticular Disease
• Intervention / Treatment: Dietary supplement: Lactoferrin CRX; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Antonio Di Sabatino, MD; Phone Number: 00390382501596; Email: a.disabatino@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be included in the trial the patient must:

• Have given written informed consent to participate
• Age ≥18 and <65 years
• Diagnosis of SUDD defined as the presence of symptoms (mainly abdominal pain, but also constipation, diarrhoea and bloating) in patients with a previous diagnosis of diverticular disease at colonoscopy or imaging in the absence of any current complication (stenoses, abscesses, fistulas)

• Women of childbearing potential are required to have a negative pregnancy test at the Baseline Visit (V1) and to use adequate contraception for the duration of the trial and for 14 days after the completion of the trial/last treatment. This includes:

  • Intrauterine Device
  • Hormonal based contraception (pill, contraceptive injection or implant etc)
  • Barrier contraception (condom and occlusive cap e.g. diaphragm or cervical cap with spermicide)
  • True abstinence (where this is in accordance with the patients preferred and usual lifestyle)

• Men are required to use adequate contraception for the entire duration of the trial and for 14 days after the completion of the trial/last treatment. This includes:

  • Barrier contraception (condom and spermicide) even if female partner(s) are using another method of contraception or are already pregnant (also to protect male partners from exposure to the trial product)
  • True abstinence (where this is in accordance with the patients preferred and usual lifestyle)

Exclusion Criteria:

The presence of any of the following will preclude patient inclusion:

• Patients diagnosed with irritable bowel syndrome, bacterial and/or parasitic intestinal diseases, inflammatory bowel disease
• Female patients who are pregnant or breastfeeding

• Use of the following medications:

  1. Use of oral or rectal 5-aminosalicylic (5-ASA) 7 days prior to enrollment
  2. Use of antibiotics for diverticular disease within the 7 days prior to enrollment
  3. Use of probiotics within the 7 days prior to enrollment
• Known history of drug or alcohol abuse within the last 3 years prior to enrollment
• Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety
• Any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period
• Active participation in other interventional or drug research in the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Lactoferrin CRX 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast)	Dietary supplement: Lactoferrin CRX; Patients will be asked to take lactoferrin CRX as already mentioned (blindly).
Placebo Comparator: B; Placebo 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast)	Other: Placebo; Patients will be asked to take placebo as already mentioned (blindly).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal 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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	4 weeks
Fecal microbiota	Evaluation of fecal microbiota after a 4-week course of lactoferrin CRX vs placebo	4 weeks

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): May 2, 2019
• Study Completion (Anticipated): November 2, 2019

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: SUDDENLY17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
• IPD Sharing Time Frame: Only on future articles that will be published.
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No