Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease
Not applicable · Testing pre-packaged low-residue diet for bowel preparation · 1 site · 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: IBD (Inflammatory Bowel Disease), Colonoscopy and Colonoscopy: Bowel Preparation.
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 1000 participants are expected to take part.
- Start date: 2026-01-01.
- Main results expected around 2026-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Bowel preparation adequacy rate (6 months)
In the researchers’ words
The primary objectives of this project are twofold: firstly, to evaluate the role of Maifu Changqing® Complete Nutrition Formula Powder in bowel preparation for colonoscopy in patients with IBD; and secondly, to enhance the nutritional support and comfort of bowel preparation for IBD patients.
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 | IBD (Inflammatory Bowel Disease); Colonoscopy; Colonoscopy: Bowel Preparation |
| Lead sponsor | Changhai Hospital |
| Collaborators | The First Affiliated Hospital of Anhui Medical University; Ankang Central Hospital; Jiangmen Central Hospital; The Affiliated Hospital of Qingdao University; RenJi Hospital; Ruijin Hospital; Shanghai 10th People's Hospital; Shengli Oilfield Hospital; First People's Hospital of Hangzhou; Subei People's Hospital of Jiangsu Province; Xijing Hospital; ShuGuang Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Enrollment | 1000 (estimated) |
| Start date | 2026-01-01 |
| Primary completion (est.) | 2026-06-30 |
| First posted | 2026-01-21 |
| Last updated | 2026-05-14 |
| Official title | Pre-packaged Low-residue Diet for Bowel Preparation in Patients With Inflammatory Bowel Disease: A National Multicenter Randomized Controlled Non-inferiority Clinical Trial |
| ClinicalTrials.gov ID | NCT07353853 |
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.Patients in this group will take a total of 2 liters of polyethylene glycol electrolyte solution for bowel preparation before colonoscopy.Stool specimens from patients will be sent for Genetic Analysis of gut microbiota.
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 (1)
| Site | City | Country | Site status |
|---|---|---|---|
| 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.