PancreatitisNCT04932785
Regular vs. Clear Liquid Diet for Mild to Moderate Acute Pancreatitis
A study testing Regular diet and Clear Liquid Diet in people with Pancreatitis and Diet, Food, and Nutrition, run by University of Southern California at 1 site in United States.
Trial summary
Acute pancreatitis is among the most common gastroenterology diagnosis in the United States, and represents a large economic burden to the United States health system. While recent guidelines agree early feeding shortens length of stay, these guidelines fail to provide recommendations on optimal diet to start leaving… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatitis, Diet, Food, and Nutrition, Diet
- What is being tested?
- Regular diet and Clear Liquid Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- 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
Who cannot join
- Pregnant or breastfeeding women
- Incarcerated patients
- Patients < 18 years of age
- Patient unable or unwilling to give informed consent
- Patients transferred from another hospital
- The possibility of poor oral intake for reasons other than acute pancreatitis (e.g. intubation, failure to pass an indicated swallow study for aspiration risk, anorexia secondary to active malignancy, etc)
Show all 10Show fewer
- Surgical intervention for infected pancreatic necrosis or pancreatic hemorrhage
- Chronic pancreatitis based on radiographic evidence
- Severe pancreatitis based on Revised Atlanta Criteria. Under Revised Atlanta Criteria, patients will be excluded if they have a composite Modified Marshall >2
- Etiologies of hypertriglyceridemia, trauma and autoimmune pancreatitis will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
LAC+USC Medical Center
Los Angeles, California, 90033
James Buxbaum, MD
About this study
Official title: To Assess the Comparative Efficacy of Full Calorie Regular Diet (RD) Versus Clear Liquid Diet (CLD) on Length of Hospital Stay (LOHS) for Mild to Moderate Acute Pancreatitis (AP)
Acute pancreatitis is among the most common gastroenterology diagnosis in the United States, and represents a large economic burden to the United States health system. While recent guidelines agree early feeding shortens length of stay, these guidelines fail to provide recommendations on optimal diet to start leaving diet type to clinician discretion. Therefore, the aim is to assess the comparative efficacy of full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP). The study population will target mild to moderate acute pancreatitis patients who can tolerate eating in a single institution. The primary end point will focus on LOHS, and secondary end points will include Pancreatic Activity Scoring System, side effects and readmission.
Read the detailed description
Purpose: To assess the comparative efficacy of initial full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP).
Study Design:
Patients presenting to the Los Angeles County Hospital with mild to moderate acute pancreatitis are eligible and are the focus population of this study. Diagnosis and severity classification will be according to the Revised Atlanta classification and Modified Marshal Score. Patients will require fulfillment of 2 of 3 criteria: amylase or lipase greater than 3 times the upper limit of normal, classic epigastric abdominal pain, or unequivocal imaging consistent with acute pancreatitis.
Patients within the inclusion and exclusion parameters will be randomized to RD vs. CLD within 16 hours of diagnosis of pancreatitis. Randomization will be performed using a random sequence algorithm with concealed allocation. The provision of diet in the emergency department prior to randomization will be recorded but not impact randomization strategy.
Following randomization, the diet of RD vs. CLD will begin as soon as patient expresses an appetite and willingness to eat. The patients will be assessed within 24 hours for hunger and interest in initiating oral feeding which accords with the 2018 recommendations of the American Gastroenterology Association for the management of acute pancreatitis.
The diet algorithm will be randomization to a 1:1 of full regular diet versus clear liquid diet per the Los Angeles County + University of Southern California nutrition department. This nutritional composition is confirmed by the in-house dietician and nutrition department. Regular diet will reflect the U.S. Department of Health and Human Services Dietary guidelines for 2015-202013 and meets recommendations of the International Consensus Guidelines for Nutrition Therapy for Pancreatitis. Fat content is modest in both groups; it is set at 20-35% of caloric intake for regular diet and 15-20% for clear liquid diet. Patients with diabetes mellitus will received modified versions of the regular or clear diet to reflect American Diabetes Association (ADA) requirements. This will be the standard of care composition provided to all patients at Los Angeles County + University of Southern California Medical Center with diabetes deemed by their providers to have a diet modified for diabetes (ADA) diet.
A complete history and physical exam will be taken at time of admission within 24 hours during time of enrollment. Then at 48 hours, 72 hours, and every day until discharge, the patient will have a targeted history including oral tolerance, pain and pain medication requirement, and baseline and changes in Pancreatic Activity Scoring System (PASS). The percent of completed diet per meal will also be recorded. At one week, patients will be contacted for symptom relapse check up by phone and at thirty days, the electronic record will be reviewed to capture possible readmissions. While patients and the study team will be unblinded following discharge, a blinded coordinator will use the length of stay function to capture the primary endpoint which is length of hospitalization.
Pain and pain medications are automatically documented in the Electronic Medical Record(EMR) for monitoring and quantification. A Wong-Baker Pain (FACES) scale is the current validated pain score used by nursing staff. Pain is recorded on a pain scale from 0-10 that matches prior landmark and contemporary studies of acute pancreatitis. Quantification of pain medication by both acetaminophen and morphine equivalents will be recorded in data collection sheets.
If patients have oral intolerance or ileus, their diet will be managed at the discretion of their treating physicians and recorded by the study team. It will be recommended that diets remain consistent and titrated in quantity per physician and patient preference; however, if there is a physician preference to change to a different diet type this will be recorded and the patient will be included in the intention to treat analysis
For severe pancreatitis that develops following enrollment, nutritional management (whether nasal jejunal tube or total parenteral nutrition) will be managed per the primary team and patients will similarly be included in the intention to treat analysis.
Gallstone pancreatitis will be diagnosed by findings of elevated or fluctuating liver enzyme tests and biliary imaging abnormalities including cholelithiasis or ductal dilation. For patients with gallstone pancreatitis who will undergo same admission cholecystectomy, patients will have diet prescribed per assigned randomization but will be made nothing by mouth (NPO) at the discretion of the surgical team in anticipation of the operation. Integration of surgery into the hospitalization may impact length of stay. Therefore, randomization will be stratified by presence of gallstone versus non-gallstone pancreatitis.
Additionally, the study protocol will not impact other strategies/treatments to manage pancreatitis. For example, alcohol counseling will be provided to those whose pancreatitis is related to heavy alcohol use regardless of randomization or the study.
- Being tested
- Regular diet, Clear Liquid Diet
- Medical subject headings
- Pancreatitis, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietOther
Regular diet
Clear Liquid DietOther
Clear Liquid Diet
| Study group | Role | What they receive |
|---|---|---|
| Regular Diet | Active comparator | Patient randomized to regular diet will begin with a regular diet. Receives: Other: Regular diet |
| Clear Liquid Diet | Active comparator | Patient randomized to clear liquid diet will begin with a clear liquid diet. Receives: Other: Clear Liquid Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization Stay
Length of Hospitalization Stay will be measured as defined as from time of admission to time of discharge for regular diet vs. clear liquid diet
Measured: From date of randomization until the date of discharge, assessed up to 24 months
Secondary outcomes (8)
Oral Intolerance
Proportion who cannot tolerate assigned diet requiring cessation or change due to worsened nausea, vomiting and pain
Measured: From date of randomization until the date of discharge, assessed up to 24 months
Intensive Care Unit admission and interventions
Intensive Care Unit admission and intervention including intubation and vasopressors
Measured: From date of randomization until the date of discharge, assessed up to 24 months
Local complications
Local complications including pancreatic necrosis, abscess, or pseudocysts
Measured: From date of randomization until the date of discharge, assessed up to 24 months
Development of severe pancreatitis
Development of severe pancreatitis as defined by the Revised Atlanta Classification (persistent single or multiple organ failure at >48 hours)
Measured: From date of randomization until the date of discharge, assessed up to 24 months
Development of severe pancreatitis
Development of severe pancreatitis as defined by the Modified Marshall Score (Score 0-4, with 4 being most severe and worse outcome)
Measured: From date of randomization until the date of discharge, assessed up to 24 months
Change in Pancreatic Activity Scoring System Score
Change in Pancreatic Activity Scoring System Score, from 0 to >250 (max score, where a max score is worse)
Measured: From date of randomization until the date of discharge at 24, 48, 72 hours and at discharge, assessed up to 24 months
Calorie and fat intake
Calorie and fat intake per group based on percent finished meal documented by nursing staff at 24, 48, and 72 hours.
Measured: From date of randomization until the date of discharge, assessed up to 24 months
30 day hospital readmission
Hospital readmission within 30 days
Measured: From date of discharge to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start18 Jul 2021
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for PancreatitisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Buxbaum, University of Southern California
- Investigators
- James Buxbaum, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932785
- Sponsor's protocol ID
- HS-20-00375
- Status last verified
- Mar 2023
- First submitted
- 7 Jun 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
PubMed 23896955Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
PubMed 30315778Jenkins A, Shapiro J. Clinical Guideline Highlights for the Hospitalist: Initial Management of Acute Pancreatitis in the Hospitalized Adult. J Hosp Med. 2019 Dec 1;14(12):764-765. doi: 10.12788/jhm.3324. Epub 2019 Oct 23.
PubMed 31634105Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
PubMed 23622135Larino-Noia J, Lindkvist B, Iglesias-Garcia J, Seijo-Rios S, Iglesias-Canle J, Dominguez-Munoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun;14(3):167-73. doi: 10.1016/j.pan.2014.02.008. Epub 2014 Mar 14.
PubMed 24854611Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. doi: 10.1016/j.cgh.2007.04.012. Epub 2007 Jul 5.
PubMed 17613280Sathiaraj E, Murthy S, Mansard MJ, Rao GV, Mahukar S, Reddy DN. Clinical trial: oral feeding with a soft diet compared with clear liquid diet as initial meal in mild acute pancreatitis. Aliment Pharmacol Ther. 2008 Sep 15;28(6):777-81. doi: 10.1111/j.1365-2036.2008.03794.x.
PubMed 19145732Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5.
PubMed 22836861Eatock FC, Chong P, Menezes N, Murray L, McKay CJ, Carter CR, Imrie CW. A randomized study of early nasogastric versus nasojejunal feeding in severe acute pancreatitis. Am J Gastroenterol. 2005 Feb;100(2):432-9. doi: 10.1111/j.1572-0241.2005.40587.x.
PubMed 15667504Rajkumar N, Karthikeyan VS, Ali SM, Sistla SC, Kate V. Clear liquid diet vs soft diet as the initial meal in patients with mild acute pancreatitis: a randomized interventional trial. Nutr Clin Pract. 2013 Jun;28(3):365-70. doi: 10.1177/0884533612466112. Epub 2012 Dec 13.
PubMed 23239793Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
PubMed 23100216Crockett S, Falck-Ytter Y, Wani S, Gardner TB. Acute Pancreatitis Guideline. Gastroenterology. 2018 Mar;154(4):1102. doi: 10.1053/j.gastro.2018.02.029. Epub 2018 Mar 2. No abstract available.
PubMed 29501369American Diabetes Association. 15. Diabetes Care in the Hospital: Standards of Medical Care in Diabetes-2020. Diabetes Care. 2020 Jan;43(Suppl 1):S193-S202. doi: 10.2337/dc20-S015.
PubMed 31862758Moraes JM, Felga GE, Chebli LA, Franco MB, Gomes CA, Gaburri PD, Zanini A, Chebli JM. A full solid diet as the initial meal in mild acute pancreatitis is safe and result in a shorter length of hospitalization: results from a prospective, randomized, controlled, double-blind clinical trial. J Clin Gastroenterol. 2010 Aug;44(7):517-22. doi: 10.1097/MCG.0b013e3181c986b3.
PubMed 20054282Buxbaum J, Quezada M, Chong B, Gupta N, Yu CY, Lane C, Da B, Leung K, Shulman I, Pandol S, Wu B. The Pancreatitis Activity Scoring System predicts clinical outcomes in acute pancreatitis: findings from a prospective cohort study. Am J Gastroenterol. 2018 May;113(5):755-764. doi: 10.1038/s41395-018-0048-1. Epub 2018 Mar 15.
PubMed 29545634
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Comparative Efficacy of Full Calorie Regular Diet (RD) Versus Clear Liquid Diet (CLD) on Length of Hospital Stay (LOHS) for Mild to Moderate Acute Pancreatitis (AP)
- ClinicalTrials.gov ID
- NCT04932785
- Acronym / sponsor ID
- HS-20-00375
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute pancreatitis is among the most common gastroenterology diagnosis in the United States, and represents a large economic burden to the United States health system. While recent guidelines agree early feeding shortens length of stay, these guidelines fail to provide recommendations on optimal diet to start leaving diet type to clinician discretion. Therefore, the aim is to assess the comparative efficacy of full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP). The study population will target mild to moderate acute pancreatitis patients who can tolerate eating in a single institution. The primary end point will focus on LOHS, and secondary end points will include Pancreatic Activity Scoring System, side effects and readmission.
Detailed description
Purpose: To assess the comparative efficacy of initial full calorie regular diet (RD) versus clear liquid diet (CLD) on length of hospital stay (LOHS) for mild to moderate acute pancreatitis (AP).
Study Design:
Patients presenting to the Los Angeles County Hospital with mild to moderate acute pancreatitis are eligible and are the focus population of this study. Diagnosis and severity classification will be according to the Revised Atlanta classification and Modified Marshal Score. Patients will require fulfillment of 2 of 3 criteria: amylase or lipase greater than 3 times the upper limit of normal, classic epigastric abdominal pain, or unequivocal imaging consistent with acute pancreatitis.
Patients within the inclusion and exclusion parameters will be randomized to RD vs. CLD within 16 hours of diagnosis of pancreatitis. Randomization will be performed using a random sequence algorithm with concealed allocation. The provision of diet in the emergency department prior to randomization will be recorded but not impact randomization strategy.
Following randomization, the diet of RD vs. CLD will begin as soon as patient expresses an appetite and willingness to eat. The patients will be assessed within 24 hours for hunger and interest in initiating oral feeding which accords with the 2018 recommendations of the American Gastroenterology Association for the management of acute pancreatitis.
The diet algorithm will be randomization to a 1:1 of full regular diet versus clear liquid diet per the Los Angeles County + University of Southern California nutrition department. This nutritional composition is confirmed by the in-house dietician and nutrition department. Regular diet will reflect the U.S. Department of Health and Human Services Dietary guidelines for 2015-202013 and meets recommendations of the International Consensus Guidelines for Nutrition Therapy for Pancreatitis. Fat content is modest in both groups; it is set at 20-35% of caloric intake for regular diet and 15-20% for clear liquid diet. Patients with diabetes mellitus will received modified versions of the regular or clear diet to reflect American Diabetes Association (ADA) requirements. This will be the standard of care composition provided to all patients at Los Angeles County + University of Southern California Medical Center with diabetes deemed by their providers to have a diet modified for diabetes (ADA) diet.
A complete history and physical exam will be taken at time of admission within 24 hours during time of enrollment. Then at 48 hours, 72 hours, and every day until discharge, the patient will have a targeted history including oral tolerance, pain and pain medication requirement, and baseline and changes in Pancreatic Activity Scoring System (PASS). The percent of completed diet per meal will also be recorded. At one week, patients will be contacted for symptom relapse check up by phone and at thirty days, the electronic record will be reviewed to capture possible readmissions. While patients and the study team will be unblinded following discharge, a blinded coordinator will use the length of stay function to capture the primary endpoint which is length of hospitalization.
Pain and pain medications are automatically documented in the Electronic Medical Record(EMR) for monitoring and quantification. A Wong-Baker Pain (FACES) scale is the current validated pain score used by nursing staff. Pain is recorded on a pain scale from 0-10 that matches prior landmark and contemporary studies of acute pancreatitis. Quantification of pain medication by both acetaminophen and morphine equivalents will be recorded in data collection sheets.
If patients have oral intolerance or ileus, their diet will be managed at the discretion of their treating physicians and recorded by the study team. It will be recommended that diets remain consistent and titrated in quantity per physician and patient preference; however, if there is a physician preference to change to a different diet type this will be recorded and the patient will be included in the intention to treat analysis
For severe pancreatitis that develops following enrollment, nutritional management (whether nasal jejunal tube or total parenteral nutrition) will be managed per the primary team and patients will similarly be included in the intention to treat analysis.
Gallstone pancreatitis will be diagnosed by findings of elevated or fluctuating liver enzyme tests and biliary imaging abnormalities including cholelithiasis or ductal dilation. For patients with gallstone pancreatitis who will undergo same admission cholecystectomy, patients will have diet prescribed per assigned randomization but will be made nothing by mouth (NPO) at the discretion of the surgical team in anticipation of the operation. Integration of surgery into the hospitalization may impact length of stay. Therefore, randomization will be stratified by presence of gallstone versus non-gallstone pancreatitis.
Additionally, the study protocol will not impact other strategies/treatments to manage pancreatitis. For example, alcohol counseling will be provided to those whose pancreatitis is related to heavy alcohol use regardless of randomization or the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Diet | Active comparator | Other: Regular dietPatient randomized to regular diet will begin with a regular diet. |
| Clear Liquid Diet | Active comparator | Other: Clear Liquid DietPatient randomized to clear liquid diet will begin with a clear liquid diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- 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
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding women
- Incarcerated patients
- Patients < 18 years of age
- Patient unable or unwilling to give informed consent
- Patients transferred from another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular dietRegular diet | Other | Regular Diet |
| Clear Liquid DietClear Liquid Diet | Other | Clear Liquid Diet |
Primary outcome
Length of Hospitalization Stay
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
Length of Hospitalization Stay will be measured as defined as from time of admission to time of discharge for regular diet vs. clear liquid diet
8 secondary outcomes
Oral Intolerance
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
Intensive Care Unit admission and interventions
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
Local complications
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
Development of severe pancreatitis
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
Development of severe pancreatitis
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
Change in Pancreatic Activity Scoring System Score
Time frame: From date of randomization until the date of discharge at 24, 48, 72 hours and at discharge, assessed up to 24 months
Calorie and fat intake
Time frame: From date of randomization until the date of discharge, assessed up to 24 months
30 day hospital readmission
Time frame: From date of discharge to 30 days after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 23896955Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.
- Background: PubMed 30315778Peery AF, Crockett SD, Murphy CC, Lund JL, Dellon ES, Williams JL, Jensen ET, Shaheen NJ, Barritt AS, Lieber SR, Kochar B, Barnes EL, Fan YC, Pate V, Galanko J, Baron TH, Sandler RS. Burden and Cost of Gastrointestinal, Liver, and Pancreatic Diseases in the United States: Update 2018. Gastroenterology. 2019 Jan;156(1):254-272.e11. doi: 10.1053/j.gastro.2018.08.063. Epub 2018 Oct 10.
- Background: PubMed 31634105Jenkins A, Shapiro J. Clinical Guideline Highlights for the Hospitalist: Initial Management of Acute Pancreatitis in the Hospitalized Adult. J Hosp Med. 2019 Dec 1;14(12):764-765. doi: 10.12788/jhm.3324. Epub 2019 Oct 23.
- Background: PubMed 23622135Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.
- Background: PubMed 24854611Larino-Noia J, Lindkvist B, Iglesias-Garcia J, Seijo-Rios S, Iglesias-Canle J, Dominguez-Munoz JE. Early and/or immediately full caloric diet versus standard refeeding in mild acute pancreatitis: a randomized open-label trial. Pancreatology. 2014 May-Jun;14(3):167-73. doi: 10.1016/j.pan.2014.02.008. Epub 2014 Mar 14.
- Background: PubMed 17613280Jacobson BC, Vander Vliet MB, Hughes MD, Maurer R, McManus K, Banks PA. A prospective, randomized trial of clear liquids versus low-fat solid diet as the initial meal in mild acute pancreatitis. Clin Gastroenterol Hepatol. 2007 Aug;5(8):946-51; quiz 886. doi: 10.1016/j.cgh.2007.04.012. Epub 2007 Jul 5.
- Background: PubMed 19145732Sathiaraj E, Murthy S, Mansard MJ, Rao GV, Mahukar S, Reddy DN. Clinical trial: oral feeding with a soft diet compared with clear liquid diet as initial meal in mild acute pancreatitis. Aliment Pharmacol Ther. 2008 Sep 15;28(6):777-81. doi: 10.1111/j.1365-2036.2008.03794.x.
- Background: PubMed 22836861Li J, Xue GJ, Liu YL, Javed MA, Zhao XL, Wan MH, Chen GY, Altaf K, Huang W, Tang WF. Early oral refeeding wisdom in patients with mild acute pancreatitis. Pancreas. 2013 Jan;42(1):88-91. doi: 10.1097/MPA.0b013e3182575fb5.
- Background: PubMed 15667504Eatock FC, Chong P, Menezes N, Murray L, McKay CJ, Carter CR, Imrie CW. A randomized study of early nasogastric versus nasojejunal feeding in severe acute pancreatitis. Am J Gastroenterol. 2005 Feb;100(2):432-9. doi: 10.1111/j.1572-0241.2005.40587.x.
- Background: PubMed 23239793Rajkumar N, Karthikeyan VS, Ali SM, Sistla SC, Kate V. Clear liquid diet vs soft diet as the initial meal in patients with mild acute pancreatitis: a randomized interventional trial. Nutr Clin Pract. 2013 Jun;28(3):365-70. doi: 10.1177/0884533612466112. Epub 2012 Dec 13.
- Background: PubMed 23100216Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
- Background: PubMed 29501369Crockett S, Falck-Ytter Y, Wani S, Gardner TB. Acute Pancreatitis Guideline. Gastroenterology. 2018 Mar;154(4):1102. doi: 10.1053/j.gastro.2018.02.029. Epub 2018 Mar 2. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Buxbaum, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular diet and Clear Liquid Diet in people with Pancreatitis and Diet, Food, and Nutrition, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Chang, MD (323-409-5050, patrick.chang@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospitalization Stay (time frame: From date of randomization until the date of discharge, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932785, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.