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Research and development of key technologies for diagnosis and treatment of irritable bowel syndrome and optimization of management system-The effect of vibrating capsule on autonomic function in chronic constipation patients: A prospective, self-controlled, multi-center clinical trial

Research and development of key technologies for diagnosis and treatment of irritable bowel syndrome and optimization of management system-The effect of vibrating capsule on autonomic function in chronic constipation patients: A prospective, self-controlled, multi-center clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100452
Enrollment
Unknown
Registered
2025-04-09
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic constipation

Interventions

Intervention Group:Swallow vibrating capsules, one capsule at a time, 2 times/week, for 4 weeks.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old; 2. Meet the diagnostic criteria for chronic constipation; 3. There are no obvious organic lesions in colonoscopy in hospitals above the second level within 3 years; 4. Willing to participate in this study and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Trying to conceive, pregnant or lactating; 2. Allergy to polymer materials; 3. Users of permanent pacemakers (e.g. implantable cardioverter-defibrillators) or any electronic/magnetic/mechanical control devices; 4. Dysphagia, gastric outlet obstruction, intestinal organic lesions (obstruction, stenosis, bleeding, inflammation or cancer, etc.); 5. Intestinal polyps or gastrointestinal ESD surgery within the past 3 months; 6. "alarm" symptoms in recent years, including abnormal weight loss (more than 10% in the last three months); 7. Have serious heart, lung, kidney and other systemic diseases; 8. Those who have been given oral drugs that are prohibited in this study in the past 2 weeks (such as gastrointestinal prokinetic drugs, intestinal emollients, antidepressants, drugs for the treatment of Parkinson's disease, opioids and other anesthetics, aluminum magnesium hydroxide, etc.); 9. Severe depression, anxiety and other mental illnesses that cannot cooperate with the completion of the study;

Design outcomes

Primary

MeasureTime frame
Heart Rate Variability;

Secondary

MeasureTime frame
Adverse events;Defecation frequency;

Countries

China

Contacts

Public ContactHou Xiaohua

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn+86 27 85726057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026