Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis
ConditionChronic Pancreatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Palatable Elemental Diet
Other interventionThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Palatable Elemental DietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)2
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.
Time frame
During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)Secondary outcomes
1
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.
Time frame
Day 28, after completion of the 14-day exclusive palatable elemental diet period2
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.
Time frame
Baseline, Day 28, and Day 563
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.
Time frame
Baseline, Day 28, and Day 56Sponsors and contacts
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Source ClinicalTrials.gov
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