Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease

Официальное название

Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease：A National Multicenter Randomized Controlled Clinical Trial

Обзор

The primary objectives of this study are as follows: 1.To evaluate the efficacy of Maifu Changqing® Complete Nutritional Formula Powder in bowel preparation for colonoscopy among inflammatory bowel disease (IBD) patients;2.To enhance nutritional status and procedural comfort during bowel preparation in the IBD population.

Подробное описание

The project workflow comprises three consecutive phases: In the initiation phase, key activities include designing the study protocol, developing a bowel preparation assessment questionnaire, and establishing collaborative multicenter partnerships. During the implementation phase, subjects will be randomized into two arms-the control arm receiving conventional low-residue diet and the intervention arm administered Maifu Changqing® Complete Nutritional Formula Powder-with both regimens initiated 24 hours prior to colonoscopy. Clinical data will be systematically collected while Case Report Forms (CRFs) from all participating centers are centrally aggregated. The conclusion phase focuses on CRF quality control through standardized verification procedures to ensure data integrity, completeness, and objectivity according to Good Clinical Practice (GCP) standards.

Вмешательства

• Пищевая добавка pre-packaged low-residue diet for bowel preparation
  Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy

Первичные конечные точки

• Bowel preparation adequacy rate [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Subject Satisfaction [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Age: Adult patients between 18 and 75 years old;
• Diagnosis of IBD according to the 2023 Guidelines for the Diagnosis and Treatment of Inflammatory Bowel Disease;
• Voluntary participation in this clinical trial and provision of signed informed consent.

Критерии исключения

• Patients with acute IBD, severe conditions, combined with major bleeding, suspected toxic megacolon, CD with severe intestinal stricture, gastrointestinal obstruction, or other conditions deemed unsuitable for colonoscopy by the physician;
• Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction;
• History of previous colorectal surgical resection or use of medications that may affect intestinal motility within one week (e.g., antidepressants, sedatives, calcium channel blockers);
• History of stroke, spinal cord injury, or psychiatric disorders that impair compliance with bowel preparation and colonoscopy;
• Allergy to any component of the administered drugs or meal replacements;
• Pregnant or lactating women, and other individuals considered unsuitable for bowel preparation and colonoscopy by the physician.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

Китай · 2 центра

• Changhai Hospital — Шанхай
• Changhai Hospital — Шанхай

Идентификаторы

NCT: NCT07165470 · CHEC2025-312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗