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NCT Number: NCT07559448

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Digestive Health Care Center

Redwood City, California, 94063, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Elemental Diet, Exclusive Oral Palatable Elemental Diet

Primary outcomes

  1. Number of Participants Who Complete at Least 12 of 14 Days of the Palatable Elemental Diet

    Time frame: During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)

    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.

  2. Number of Participants Who Consume at Least 75% of Prescribed Palatable Elemental Diet Calories

    Time frame: During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)

    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.

Secondary outcomes

  1. Participant-Reported Acceptability of the Palatable Elemental Diet

    Time frame: Day 28, after completion of the 14-day exclusive palatable elemental diet period

    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.

  2. Change From Baseline in Structured Assessment of Gastrointestinal Symptoms Global Symptom Burden Score

    Time frame: Baseline, Day 28, and Day 56

    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.

  3. Change From Baseline in Patient-Reported Outcomes Measurement Information System Global Health Version 1.2 (PROMIS Global Health v1.2) Summary Score

    Time frame: Baseline, Day 28, and Day 56

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Leung

CONTACT

[email protected]

(650) 725-3370

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Cedars-Sinai Medical Center
  • mBIOTA

Registry information

Official study title

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

Acronym: PEACE-CP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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