An interventional study of Lactoferrin CRX and Placebo in Diverticular Disease and Symptomatic Uncomplicated Diverticular Disease, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-10.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Treatment
Among 11 studies in Diverticular Diseases with a site in Italy — 2 open to participants now, 3 under way, none of them phase 3. Diverticular Diseases · Italy.
Among the 11 studies in Diverticular Diseases with a site in Italy, this one is the only one that started in 2018, is one of 3 with no phase, and was the 6th registered.
44 studies on the registry are indexed under Diverticular Diseases; 9 are open to participants now.
This study's planned enrollment of 30 is below the median of 81 across 31 interventional studies indexed under Diverticular Diseases.
Browse Diverticular Diseases studies →2 of the 11 studies in Diverticular Diseases with a site in Italy are open now, in 1 country. Each count lists the studies.
Of the 6 Diverticular Diseases studies recruiting now, 4 (67%) set no upper age limit and 1 (17%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
Median enrollment 80 across the 7 interventional studies, 250 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
1 of 11 have an industry lead sponsor. The 10 most frequent:
Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.
Fondazione IRCCS Policlinico San Matteo di Pavia has 1 study filed under Diverticular Diseases — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Diverticular Diseases with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be included in the trial the patient must:
Women of are required to have a negative pregnancy test at the Baseline Visit (V1) and to use adequate 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:
Exclusion Criteria:
The presence of any of the following will preclude patient inclusion:
Use of the following medications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lactoferrin CRX 100 mg, capsule formulation, 2 tablets taken together once daily, on an empty stomach (before breakfast)
Dietary Supplement: Lactoferrin CRX
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 lactoferrin CRX as already mentioned (blindly).
Patients will be asked to take placebo as already mentioned (blindly).
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.
Time frame: 4 weeks
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.
Time frame: 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)
Time frame: 4 weeks
Fecal microbiota
Evaluation of fecal microbiota after a 4-week course of lactoferrin CRX vs placebo
Time frame: 4 weeks
Plan to share: Yes — All individual participant data (IPD), anonymized and aggregated, that underlie results in a publication.
Supporting information: Statistical analysis plan, Clinical study report
Time frame: Only on future articles that will be published.
No publications or documents are linked to this record.
Started Jun 2018 (actual). Primary completion is estimated for May 2019, 11 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Policlinico San Matteo di Pavia →