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Regular vs Clear Liquid Diet for Pancreatitis
N/A
Recruiting
Led By James Buxbaum, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presentation with acute pancreatitis as defined by two of three criterion per the Revised Atlanta Criteria guidelines: (a) Amylase or lipase > 3x the upper limit of normal, b) Classical abdominal pain, c) Ultrasound or computed tomography of unequivocal pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding
18 years of age or older
Must not have
Etiologies of hypertriglyceridemia, trauma and autoimmune pancreatitis will be excluded
Surgical intervention for infected pancreatic necrosis or pancreatic hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of discharge at 24, 48, 72 hours and at discharge, assessed up to 24 months
Awards & highlights
Summary
This trial is testing whether a full calorie diet or a clear liquid diet is better for people with mild to moderate acute pancreatitis when it comes to length of hospital stay.
Who is the study for?
This trial is for adults over 18 with mild to moderate acute pancreatitis, confirmed by specific diagnostic criteria. It's not for pregnant or breastfeeding women, those unable to consent, transferred from other hospitals, with chronic/severe pancreatitis, certain etiologies like hypertriglyceridemia or trauma, and those who can't eat orally due to other medical issues.
What is being tested?
The study compares the effects of a full calorie regular diet (RD) versus a clear liquid diet (CLD) on hospital stay length in patients with mild to moderate acute pancreatitis. The main goal is seeing if one diet type helps patients leave the hospital sooner.
What are the potential side effects?
Potential side effects are not specified but may include digestive discomfort or nutritional deficiencies depending on individual tolerance and response to either the regular or clear liquid diets prescribed during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have acute pancreatitis according to the Atlanta Criteria.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My high triglycerides are not due to trauma, autoimmune pancreatitis, or other causes.
Select...
I had surgery for infected pancreatic tissue or bleeding.
Select...
I am under 18 years old.
Select...
I cannot or do not want to give permission for treatment.
Select...
I do not have severe pancreatitis according to the Revised Atlanta Criteria.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of discharge at 24, 48, 72 hours and at discharge, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of discharge at 24, 48, 72 hours and at discharge, assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of Hospitalization Stay
Secondary outcome measures
30 day hospital readmission
Calorie and fat intake
Change in Pancreatic Activity Scoring System Score
+4 moreTrial Design
2Treatment groups
Active Control
Group I: Regular DietActive Control1 Intervention
Patient randomized to regular diet will begin with a regular diet.
Group II: Clear Liquid DietActive Control1 Intervention
Patient randomized to clear liquid diet will begin with a clear liquid diet.
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
919 Previous Clinical Trials
1,611,291 Total Patients Enrolled
James Buxbaum, MDPrincipal InvestigatorPrincipal Investigator
6 Previous Clinical Trials
960 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My high triglycerides are not due to trauma, autoimmune pancreatitis, or other causes.I had surgery for infected pancreatic tissue or bleeding.I have trouble eating for reasons not related to acute pancreatitis.I have acute pancreatitis according to the Atlanta Criteria.I am under 18 years old.I cannot or do not want to give permission for treatment.I am 18 years old or older.I do not have severe pancreatitis according to the Revised Atlanta Criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Regular Diet
- Group 2: Clear Liquid Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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