Chronic PancreatitisPEACE-CPNCT07559448
Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis
A study testing Palatable Elemental Diet in people with Chronic Pancreatitis, run by Stanford University at 1 site in United States.
Trial 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. An elemental diet is a nutritionally complete formula made from ingredients that are easy to absorb. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Palatable Elemental Diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford Digestive Health Care Center
Redwood City, California, 94063
About this study
Official title: 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Palatable Elemental Diet
- Keywords
- chronic pancreatitis, elemental diet, palatable elemental diet, gastrointestinal symptoms, abdominal pain, microbiome, feasibility study
- Medical subject headings
- Pancreatitis, Chronic, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatable Elemental DietOther
Also called Elemental Diet, Exclusive Oral 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Palatable Elemental Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)
Secondary outcomes (3)
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.
Measured: Day 28, after completion of the 14-day exclusive palatable elemental diet period
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.
Measured: 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.
Measured: Baseline, Day 28, and Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm feasibility study in which all participants receive a 14-day exclusive oral palatable elemental diet followed by 4 weeks of post-intervention follow-up.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, mBIOTA
- Responsible party
- Principal investigator, Yi Jiang, Stanford University
- Investigators
- Yi Jiang, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559448
- Sponsor's protocol ID
- 84595
- Acronym
- PEACE-CP
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Novel Oral Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT07559448
- Acronym / sponsor ID
- PEACE-CP / 84595
- Conditions
- Chronic Pancreatitis
- Keywords
- chronic pancreatitis, elemental diet, palatable elemental diet, gastrointestinal symptoms, abdominal pain, microbiome, feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center, mBIOTA
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 30 Apr 2026 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm feasibility study in which all participants receive a 14-day exclusive oral palatable elemental diet followed by 4 weeks of post-intervention follow-up.
| Arm | Type | Receives |
|---|---|---|
| Palatable Elemental Diet | Experimental | Other: Palatable Elemental DietParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Palatable Elemental DietAlso: Elemental Diet, Exclusive Oral Palatable Elemental DietThe 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 | Palatable Elemental Diet |
Primary outcome
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.
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.
3 secondary outcomes
Participant-Reported Acceptability of the Palatable Elemental Diet
Time frame: Day 28, after completion of the 14-day exclusive palatable elemental diet period
Change From Baseline in Structured Assessment of Gastrointestinal Symptoms Global Symptom Burden Score
Time frame: 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
Time frame: Baseline, Day 28, and Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- 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.
Yi Jiang, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatable Elemental Diet in people with Chronic Pancreatitis, run by Stanford University 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Leung ((650) 725-3370, aleung13@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.