Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease
Not applicable · Testing pre-packaged low-residue diet for bowel preparation · 2 sites · Changhai Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing pre-packaged low-residue diet for bowel preparation (a dietary supplement) as a way to diagnose or measure disease. Condition(s) listed: Colonoscopy: Bowel Preparation and IBD - Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 500 participants are expected to take part.
- Start date: 2025-09-01.
- Main results expected around 2026-12-31 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in China.
Main thing being measured
- Bowel preparation adequacy rate (6 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Colonoscopy: Bowel Preparation; IBD - Inflammatory Bowel Disease |
| Lead sponsor | Changhai Hospital |
| Collaborators | The First Affiliated Hospital of Anhui Medical University; Ankang Central Hospital; First People's Hospital of Hangzhou; Jiangmen Central Hospital; Subei People's Hospital of Jiangsu Province; Xijing Hospital; The Affiliated Hospital of Qingdao University; RenJi Hospital; Ruijin Hospital; Shanghai 10th People's Hospital; ShuGuang Hospital; Shengli Oilfield Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Enrollment | 500 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2026-12-31 |
| First posted | 2025-09-10 |
| Last updated | 2026-05-14 |
| Official title | Pre-Packaged Low-Residue Diet Assisting Bowel Preparation in Patients With Inflammatory Bowel Disease：A National Multicenter Randomized Controlled Clinical Trial |
| ClinicalTrials.gov ID | NCT07165470 |
Interventions
- pre-packaged low-residue diet for bowel preparation (Dietary Supplement)
Participants will be provided with 6 sachets of pre-packaged low-residue diet one day prior to colonoscopy
Full eligibility criteria (from the record)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai Hospital | Shanghai, Shanghai Municipality | China | Recruiting |
| Changhai Hospital | Shanghai, Shanghai Municipality | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.