Palatable Elemental Diet for gAstrointestinal Symptoms in Chronic PancrEatitis

NCT07559448 | Not Yet Recruiting

• 1 other identifier: 84595
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitis; elemental diet; palatable elemental diet; gastrointestinal symptoms; abdominal pain; microbiome; feasibility study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change From Baseline in SAGIS Global Symptom Burden Score

  Baseline, Day 28 (end of PED), and Day 56

• Change From Baseline in PROMIS Global Health v1.2 Summary Score

  Baseline, Day 28 (end of PED), and Day 56

• Change From Baseline in Selected PROMIS-29 v2.0 Domain Scores

  Baseline, Day 28 (end of PED), and Day 56

Study Arms (1)

Palatable Elemental Diet

EXPERIMENTAL

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

Interventions

Palatable Elemental Diet OTHER

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.

Also known as: PED, Elemental Diet, Exclusive Oral Palatable Elemental Diet

Palatable Elemental Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Cedars-Sinai Medical Center: collaborator
• mBIOTA: collaborator

Study Sites (1)

Stanford Digestive Health Care Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic; Abdominal Pain

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Yi Jiang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Leung

CONTACT

(650) 725-3370; aleung13@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: This is a single-arm feasibility study in which all participants receive a 14-day exclusive palatable elemental diet followed by 4 weeks of post-intervention follow-up.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)