Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease

NCT03490279 | Unknown DMC

• 1 other identifier: SUDDENLY17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diverticular Disease; Symptomatic Uncomplicated Diverticular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptom-free remission

  4 week

• 36-item short form survey (SF-36)

  4 weeks

• Fecal microbiota

  4 weeks

Study Arms (2)

A

EXPERIMENTAL

Lactoferrin CRX 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast)

Dietary Supplement: Lactoferrin CRX

B

PLACEBO COMPARATOR

Placebo 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast)

Other: Placebo

Interventions

Lactoferrin CRX DIETARY_SUPPLEMENT

Patients will be asked to take lactoferrin CRX as already mentioned (blindly).

A

Placebo OTHER

Patients will be asked to take placebo as already mentioned (blindly).

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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:
• Use of oral or rectal 5-aminosalicylic (5-ASA) 7 days prior to enrollment
• Use of antibiotics for diverticular disease within the 7 days prior to enrollment
• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Diverticular Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Internal Medicine

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: June 1, 2018
• Primary Completion: May 2, 2019
• Study Completion: November 2, 2019
• Last Updated: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: Only on future articles that will be published.

Locations

IT (1)