Diverticular DiseaseSUDDENLYNCT03490279
Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease
A study testing Lactoferrin CRX in people with Diverticular Disease and Symptomatic Uncomplicated Diverticular Disease, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diverticular Disease, Symptomatic Uncomplicated Diverticular Disease
- What is being tested?
- Lactoferrin CRX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 2 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Antonio Di Sabatino, MD, 00390382501596, a.disabatino@smatteo.pv.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Lactoferrin CRX, Placebo
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin CRXDietary supplement
Patients will be asked to take lactoferrin CRX as already mentioned (blindly).
PlaceboOther
Patients will be asked to take placebo as already mentioned (blindly).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Lactoferrin CRX 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast) Receives: Dietary Supplement: Lactoferrin CRX |
| B | Placebo comparator | Placebo 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 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)
Measured: 4 weeks
Fecal microbiota
Evaluation of fecal microbiota after a 4-week course of lactoferrin CRX vs placebo
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start1 Jun 2018
- Primary completion2 May 2019 (estimated)
- Study completion2 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Di Sabatino, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490279
- Sponsor's protocol ID
- SUDDENLY17
- Acronym
- SUDDENLY
- Status last verified
- Aug 2018
- First submitted
- 30 Mar 2018
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Uncomplicated Diverticular Disease: a lactofErriN piLot studY
- ClinicalTrials.gov ID
- NCT03490279
- Acronym / sponsor ID
- SUDDENLY / SUDDENLY17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 2 May 2019 (estimated)
- Study completion
- 2 Nov 2019 (estimated)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Lactoferrin CRXLactoferrin CRX 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast) |
| B | Placebo comparator | Other: PlaceboPlacebo 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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:
Key exclusion criteria (11 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactoferrin CRXPatients will be asked to take lactoferrin CRX as already mentioned (blindly). | Dietary supplement | A |
| PlaceboPatients will be asked to take placebo as already mentioned (blindly). | Other | B |
Primary outcome
Abdominal symptoms reduction
Time frame: 4 weeks
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.
3 secondary outcomes
Symptom-free remission
Time frame: 4 week
36-item short form survey (SF-36)
Time frame: 4 weeks
Fecal microbiota
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactoferrin CRX in people with Diverticular Disease and Symptomatic Uncomplicated Diverticular Disease, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal symptoms reduction (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.