Feasibility of a Novel Oral Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants Who Complete at Least 12 of 14 Days of the Palatable Elemental Diet
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Palatable Elemental Diet
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.
干预措施: Palatable Elemental Diet (Other)
结局指标
主要结局
Number of Participants Who Complete at Least 12 of 14 Days of the Palatable Elemental Diet
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in SAGIS Global Symptom Burden Score(Baseline, Day 28 (end of PED), and Day 56)
- Change From Baseline in PROMIS Global Health v1.2 Summary Score(Baseline, Day 28 (end of PED), and Day 56)
- Change From Baseline in Selected PROMIS-29 v2.0 Domain Scores(Baseline, Day 28 (end of PED), and Day 56)
研究者
Yi Jiang
Assistant Clinical Professor
Stanford University