Effects of dietary fat on pancreatitis recurrence
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
This study is testing if a low-fat diet can help people who have had multiple episodes of acute pancreatitis avoid getting it again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | University of Pecs Academic / other |
| Locations | 1 site (Budapest) |
| Trial ID | NCT04761523 on ClinicalTrials.gov |
What this trial studies
This trial investigates how different dietary fat contents affect the recurrence of acute pancreatitis and associated mortality. Participants with a history of at least two episodes of acute pancreatitis will be randomized into two groups: one following a reduced fat diet and the other adhering to a standard healthy diet. Over a two-year period, participants will receive dietary interventions and complete food frequency questionnaires, while their health data, including mortality, BMI, and serum lipid levels, will be monitored. The goal is to determine if a low-fat diet can effectively reduce the recurrence of acute pancreatitis in idiopathic cases.
Who should consider this trial
Good fit: Ideal candidates are individuals over 14 years old who have experienced at least two episodes of acute pancreatitis in the past two years, with the last episode being idiopathic.
Not a fit: Patients with critical conditions, active malignancies, or those receiving regular nutritional guidance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a dietary intervention to significantly reduce the recurrence of acute pancreatitis in patients.
How similar studies have performed: While dietary interventions have been suggested, this specific approach to reducing dietary fat in pancreatitis patients is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with * The last episode being idiopathic, who are * Older than 14 years. Exclusion Criteria: * Individuals already receiving regular nutritional guidance (with medical indication), * Individuals in critical condition or in terminal stage of cancer (with an expected survival \<2 years) , * Individuals undergoing treatment for active malignancy, * Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / HbA1c \>6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus) * Individuals with known cholecystolithiasis * Individuals who are pregnant or nursing * Individuals with a BMI \< 18.5 * Individuals who are regularly receiving systemic corticosteroids * Individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.
Where this trial is running
Budapest
- Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University — Budapest, Hungary (Recruiting)
Study contacts
- Study coordinator: Péter Hegyi, MD, PhD, DSc
- Email: hegyi2009@gmail.com
- Phone: +36703751031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.