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| Name | Class |
|---|---|
| Cedars-Sinai Medical Center | OTHER |
| mBIOTA | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Leung | Contact | (650) 725-3370 | aleung13@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yi Jiang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Digestive Health Care Center | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D005526 | Food, Formulated |
| ID | Term |
|---|---|
| D019648 | Foods, Specialized |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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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.
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| 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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D019602 |
| Food and Beverages |