Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis (PEACE-CP)

Feasibility of a Novel Oral Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis

The goal of this clinical trial is to learn whether a 2-week exclusive palatable elemental diet is feasible, tolerable, and acceptable for adults with chronic pancreatitis and bothersome gastrointestinal symptoms. An elemental diet is a nutritionally complete formula made from ingredients that are easy to absorb. The main questions it aims to answer are whether participants can complete the diet as planned, and whether they can take in most of the prescribed formula, and how acceptable the study diet is to participants at the end of the 2-week diet period.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Other: Palatable Elemental Diet

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Leung; Phone Number: (650) 725-3370; Email: aleung13@stanford.edu

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Stanford Digestive Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 to 75 years
• Clinical diagnosis of chronic pancreatitis based on medical history and study physician assessment
• Self-reported chronic pancreatitis-related gastrointestinal symptoms within 30 days before enrollment, with significant global gastrointestinal symptom burden defined as a Structured Assessment of Gastrointestinal Symptoms (SAGIS) score of 16 or higher

Exclusion Criteria:

• Pancreatic tumor or pancreatic cancer
• History of pancreatic surgery
• Pregnancy or breastfeeding
• Diagnosis of a condition other than chronic pancreatitis that contributes to gastrointestinal symptoms, based on medical history or study physician assessment
• Active infection or antibiotic use within the last month
• History of phenylketonuria
• Insulin-dependent diabetes or diabetes requiring insulin treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Palatable Elemental Diet; Participants in this single-arm study will consume an exclusive oral palatable elemental diet for 14 days. During the intervention period, participants will complete daily diet and symptom diaries and undergo study assessments, including questionnaires and biospecimen collection. After the 14-day diet period, participants will resume their usual diet and continue follow-up for 4 additional weeks.

Other: Palatable Elemental Diet; The intervention is an exclusive oral palatable elemental diet administered for 14 consecutive days as the participant's sole nutritional intake. This amino acid-based formula was developed to provide an elemental diet with improved palatability and tolerability. Following completion of the 14-day diet period, participants will return to their usual diet and undergo 4 additional weeks of follow-up.; Other Names: Elemental Diet; Exclusive Oral Palatable Elemental Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Complete at Least 12 of 14 Days of the Palatable Elemental Diet	Completion is defined as completing at least 12 of the 14 study diet days during the exclusive palatable elemental diet period. The feasibility target is that at least 80% of participants meet this criterion.	During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)
Number of Participants Who Consume at Least 75% of Prescribed Palatable Elemental Diet Calories	Diet adherence is defined as consuming at least 75% of prescribed palatable elemental diet calories during the 14-day exclusive diet period, based on daily diary tracking. The feasibility target is that at least 75% of participants meet this criterion.	During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Structured Assessment of Gastrointestinal Symptoms Global Symptom Burden Score	Structured Assessment of Gastrointestinal Symptoms total score. The instrument uses 22 Likert-scale questions to calculate total gastrointestinal symptom burden, with a total score range of 0 to 88. Higher scores indicate worse gastrointestinal symptom burden.	Baseline, Day 28, and Day 56
Change From Baseline in Patient-Reported Outcomes Measurement Information System Global Health Version 1.2 (PROMIS Global Health v1.2) Summary Score	PROMIS Global Health v1.2 summary score derived from the 10-item questionnaire administered at study visits. The instrument assesses general, physical, mental, and social health, including physical function, emotional problems, fatigue, and pain. Nine items use 5-point response scales and 1 pain item uses a 0-to-10 scale. Higher scores indicate better global health overall.	Baseline, Day 28, and Day 56
Participant-Reported Acceptability of the Palatable Elemental Diet	Acceptability will be assessed using participant-reported questionnaire items completed at Day 28. Items will assess organoleptic acceptability of the study diet, including appearance, smell, taste, aftertaste, and consistency, as well as overall acceptability. Responses will be summarized descriptively.	Day 28, after completion of the 14-day exclusive palatable elemental diet period

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Cedars-Sinai Medical Center; mBIOTA
• Investigators: Principal Investigator: Yi Jiang, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: microbiome; feasibility study; abdominal pain; chronic pancreatitis; gastrointestinal symptoms; elemental diet; palatable elemental diet
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Chronic Disease; Disease Attributes; Signs and Symptoms, Digestive; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pancreatitis; Abdominal Pain; Pancreatitis, Chronic; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Foods, Specialized; Food, Formulated
• Other Study ID Numbers: 84595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No