Chronic Pancreatitis
Conditions
Keywords
chronic pancreatitis, elemental diet, palatable elemental diet, gastrointestinal symptoms, abdominal pain, microbiome, feasibility study
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. 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.
Interventions
OTHERPalatable 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.
Sponsors
Stanford University
Cedars-Sinai Medical Center
mBIOTA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete at Least 12 of 14 Days of the Palatable Elemental Diet | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Participant-Reported Acceptability of the Palatable Elemental Diet | 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. |
| Change From Baseline in Structured Assessment of Gastrointestinal Symptoms Global Symptom Burden Score | 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. |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Global Health Version 1.2 (PROMIS Global Health v1.2) Summary Score | 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. |
Countries
United States
Contacts
CONTACTAndrea Leung
PRINCIPAL_INVESTIGATORYi Jiang, MD
Stanford University
Outcome results
None listed