Lactoferrin for the Treatment of Symptomatic Uncomplicated Diverticular Disease

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.