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

Primary Purpose

Diverticular Disease, Symptomatic Uncomplicated Diverticular Disease

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Lactoferrin CRX

Placebo

About this trial

This is an interventional treatment trial for Diverticular Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fondazione IRCCS Policlinico San MatteoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

Fecal microbiota

Evaluation of fecal microbiota after a 4-week course of lactoferrin CRX vs placebo

Full Information

NCT ID

NCT03490279

First Posted

March 30, 2018

Last Updated

August 8, 2018

Sponsor

IRCCS Policlinico S. Matteo

1. Study Identification

Unique Protocol Identification Number

NCT03490279

Brief Title

Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease

Acronym

SUDDENLY

Official Title

Symptomatic Uncomplicated Diverticular Disease: a lactofErriN piLot studY

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

May 2, 2019 (Anticipated)

Study Completion Date

November 2, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Policlinico S. Matteo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diverticular Disease, Symptomatic Uncomplicated Diverticular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactoferrin CRX

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Abdominal symptoms reduction

Description

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

Secondary Outcome Measure Information:

Title

Symptom-free remission

Description

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

Title

36-item short form survey (SF-36)

Description

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

Title

Fecal microbiota

Description

Evaluation of fecal microbiota after a 4-week course of lactoferrin CRX vs placebo

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Facility Information:

Facility Name

Fondazione IRCCS Policlinico San Matteo

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio Di Sabatino, MD

Phone

00390382501596

a.disabatino@smatteo.pv.it

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease

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