Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis

Официальное название

Feasibility of a Novel Oral Palatable Elemental Diet for Gastrointestinal Symptoms in Chronic Pancreatitis

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Number of Participants Who Complete at Least 12 of 14 Days of the Palatable Elemental Diet [Срок оценки: 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 [Срок оценки: During the 14-day exclusive palatable elemental diet period (Day 14 to Day 28)]

Вторичные конечные точки (3)

• Participant-Reported Acceptability of the Palatable Elemental Diet [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline, Day 28, and Day 56]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford Digestive Health Care Center — Redwood City

Идентификаторы

NCT: NCT07559448 · 84595

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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