Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT06797739
Active, not recruiting Not applicable

Effect of Nutritional Counseling and Mediterranean Diet on Patients With Diverticular Disease

NCT06797739 · tracked via the Priya Life Science Italy tracker
Sponsor
Regione del Veneto - AULSS n. 7 Pedemontana
Phase
Not applicable
Started
2023-04-04
Last updated
2025-01-28

Condition(s) studied

Diverticular Diseases

Investigational drug(s) / intervention(s)

Nutritional counsellingDiet

Nutritional counselling: Patients will be asked to follow the Mediterranean Diet and to participate to an educational program.

Diet: Patients will be asked to follow Mediterranean Diet only

Study summary

Diverticular Disease (DD) is a frequent condition in Western populations and may be associated with complications including bleeding, perforation, acute diverticulitis, and colon strictures. Severity of diverticular disease and its association with prognosis in relation to surgery using the Diverticular Inflammation and Complication Assessment (DICA) classification has been validated in several studies. A sedentary lifestyle, poor fibre intake and other unhealthy dietary habits have been associated with DD. On the contrary, the Mediterranean Diet (MD), which involves factors such as consuming locally grown food products, family meals, conviviality, involvement in the preparation of meals, as well as high intake of vegetables, legumes, fruit and cereals, medium intake of fish, low intake of meat and saturated fat, high intake of unsaturated fat (particularly olive oil), a medium-low intake of dairy products (yogurt and cheese), and a moderate intake of wine, seems to protect against DD. Moreover, populations that follow the MD pattern show a 50% lower rate of cardiovascular mortality due to cardiovascular disease and show highest longevity. A common finding in clinical practice is that a majority of patients undergoing a new diet stop to correctly follow the diet in the long term, suggesting the importance of periodic counselling for patients.

The aim of the study is to evaluate the impact of MD on DD and on severity of DD, and to explore the impact of incorporating a dietitian-driven counselling program in this condition.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Have given written informed consent to participate * Diagnosis of SUDD defined as the presence of symptoms (mainly abdominal pain, but also constipation, diarrhea and bloating) in patients with a previous diagnosis of diverticular disease at colonoscopy in the absence of any current complications (stenoses, abscesses, fistulas) * DICA assessment during a colonoscopy Exclusion Criteria: * Acute or complicated diverticulitis * Hospitalized patients * Patients with active oncological diseases. * Former partial or total colonic resection or other surgical procedures for DD * Short bowel syndrome or active perianal fistulas * Female patients who are pregnant or breastfeeding * Patients with known malabsorption diseases (e.g. celiac disease) * 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 * Patients undergoing a specific diet (e.g. diet for diabetics) * Patients with known and well-established food allergies or intolerance to dietary elements of MD * Patients with recent diagnosis of or non-controlled lactose intolerance * Active participation in other interventional or drug research projects in the study period.

Primary outcome measure(s)

  • Remission of symptoms — 12 weeks
    The percentage of patients that will achieve symptom-free remission of symptoms
  • Adherence to diet — 12 weeks
    The effect of a counselling program on Medi-LITE score
  • DICA and diet — 12 weeks
    The differences in response based on basal DICA (Diverticular Inflammation and Complication Assessment, value 1-3, with DICA 3 meaning a worse outcome).

Trial sites (1)

FacilityCityRegionStatus
UOSD Endoscopia - Ospedale Alto Vicentino - AULSS 7 Pedemontana Santorso Vicenza

More Regione del Veneto - AULSS n. 7 Pedemontana trials in Italy

Non-invasive Hemodynamic Optimization of Sepsis in Internal Medicine: a Randomized Study Comparing Therapy Guided by Non-invasive Hemodynamic Indices Versus Standard of Care. Recruiting
COMPARISON OF BANDAGE IN HAND EDEMA Enrolling by invitation

Other trials for the same condition

RObotic Versus LAparoscopic Colectomy for DIverticulitis. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06797739 on ClinicalTrials.gov ↗ ← All trials in Italy