Regular vs. Clear Liquid Diet for Mild to Moderate Acute Pancreatitis

NCT04932785 | Unknown DMC

• 1 other identifier: HS-20-00375
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pancreatitis; Diet, Food, and Nutrition; Diet; Pancreatic Disease; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

  From date of randomization until the date of discharge, assessed up to 24 months

Secondary Outcomes (8)

• Oral Intolerance

  From date of randomization until the date of discharge, assessed up to 24 months

• Intensive Care Unit admission and interventions

  From date of randomization until the date of discharge, assessed up to 24 months

• Local complications

  From date of randomization until the date of discharge, assessed up to 24 months

• Development of severe pancreatitis

  From date of randomization until the date of discharge, assessed up to 24 months

• Development of severe pancreatitis

  From date of randomization until the date of discharge, assessed up to 24 months

Study Arms (2)

Regular Diet

ACTIVE COMPARATOR

Patient randomized to regular diet will begin with a regular diet.

Other: Regular diet

Clear Liquid Diet

ACTIVE COMPARATOR

Patient randomized to clear liquid diet will begin with a clear liquid diet.

Other: Clear Liquid Diet

Interventions

Regular diet OTHER

Regular diet

Regular Diet

Clear Liquid Diet OTHER

Clear Liquid Diet

Clear Liquid Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

LAC+USC Medical Center

Los Angeles, California, 90033, United States

RECRUITING

Related Publications (23)

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  PMID: 23896955 BACKGROUND

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  PMID: 24854611 BACKGROUND

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• Sathiaraj 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.

  PMID: 19145732 BACKGROUND

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• Eatock 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.

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• Rajkumar 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.

  PMID: 23239793 BACKGROUND

• Banks 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.

  PMID: 23100216 BACKGROUND

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• American 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.

  PMID: 31862758 BACKGROUND

• Moraes 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.

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• Buxbaum 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.

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• Horibe M, Iwasaki E, Nakagawa A, Matsuzaki J, Minami K, Machida Y, Tamagawa H, Takimoto Y, Ueda M, Katayama T, Kawasaki S, Matsushita M, Seino T, Fukuhara S, Kanai T. Efficacy and safety of immediate oral intake in patients with mild acute pancreatitis: A randomized controlled trial. Nutrition. 2020 Jun;74:110724. doi: 10.1016/j.nut.2020.110724. Epub 2020 Jan 15.

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• Working Party of the British Society of Gastroenterology; Association of Surgeons of Great Britain and Ireland; Pancreatic Society of Great Britain and Ireland; Association of Upper GI Surgeons of Great Britain and Ireland. UK guidelines for the management of acute pancreatitis. Gut. 2005 May;54 Suppl 3(Suppl 3):iii1-9. doi: 10.1136/gut.2004.057026. No abstract available.

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• Mirtallo JM, Forbes A, McClave SA, Jensen GL, Waitzberg DL, Davies AR; International Consensus Guideline Committee Pancreatitis Task Force. International consensus guidelines for nutrition therapy in pancreatitis. JPEN J Parenter Enteral Nutr. 2012 May;36(3):284-91. doi: 10.1177/0148607112440823. Epub 2012 Mar 28.

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  PMID: 12056792 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Pancreatic Diseases

Interventions

Diet

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• James Buxbaum, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Chang, MD

CONTACT

323-409-5050; patrick.chang@med.usc.edu

Jessica Serna, BS

CONTACT

323-409-6939; jessica.serna@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology Los Angeles County + University of Southern California

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 21, 2021
• Study Start: July 18, 2021
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)