Comparing bowel preparation methods for capsule endoscopy
Evaluation of Different Bowel Preparations in Magnetically Controlled Capsule Endoscopy: a Randomized Controlled Study
This study tests which of three different ways to prepare your bowels—normal diet, low residue diet, or laxative cleaning—gives the best pictures during a capsule endoscopy for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 375 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan) |
| Trial ID | NCT06313242 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of three different bowel preparation methods—normal diet, low residue diet, and laxative cleaning—on the image quality of magnetically controlled capsule endoscopy. It evaluates factors such as examination completion rates, small intestine transit time, lesion detection, patient tolerance, and safety associated with each preparation method. The goal is to determine which method provides the best outcomes for patients undergoing this type of endoscopy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with indications for small bowel examination, such as unexplained gastrointestinal bleeding or suspected Crohn's disease.
Not a fit: Patients with known gastrointestinal obstructions, swallowing disorders, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness and safety of magnetically controlled capsule endoscopy for patients.
How similar studies have performed: While this approach is not widely tested, similar studies have shown varying success in optimizing bowel preparation for endoscopic procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years, male or female 2. One of the following examination indications: (1) Unexplained gastrointestinal bleeding; (2) Unexplained iron deficiency anaemia; (3) Suspected Crohn's disease or monitoring and directing treatment for Crohn's disease; (4) Suspected small bowel tumour; (5) Monitoring the development of small bowel polyposis syndrome; (6) Suspected or difficult to control malabsorption syndromes (e.g., celiac disease, etc.); (7) Detection of NSAID-associated small bowel mucosal damage; (8) Those with a clinical need to exclude small bowel disease. Exclusion Criteria: 1. People who are ineligible for surgery or refuse to undergo any abdominal surgery (once the capsule is retained it cannot be removed surgically); 2. Known or suspected gastrointestinal obstruction, stenosis, and fistula; 3. People with implanted cardiac pacemakers or other electronic devices; 4. People with swallowing disorders; 5. Women during pregnancy; 6. People who are unable or unwilling to provide informed consent.
Where this trial is running
Jinan
- Qilu Hospital of Shandong University — Jinan, China (Recruiting)
Study contacts
- Study coordinator: Feixue Chen, Ph.D
- Email: chenfeixue@email.sdu.edu.cn
- Phone: 18560086108
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.