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Monitoring the motility of the gastrointestinal tract by the microcapsule image and biodynamic analyzer

Monitoring the motility of the gastrointestinal tract by the microcapsule image and biodynamic analyzer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800017976
Enrollment
Unknown
Registered
2018-08-25
Start date
2018-08-24
Completion date
Unknown
Last updated
2018-08-27

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

Conditions

Functional gastrointestinal diseases

Interventions

Gold Standard:Clinical outcome: 1. Utilize high resolution esophageal manometry as referance standards for esophageal motiity disorders
2. Utilize electrogastrogram and gastric emptying test as referance standards for functional dispepsia and diabetic gastroparesis
3. Utilize anorectal manometry and colonic transit test as referance standards for
Index test:Microcapsule&#32
image&#32
and&#32
biodynamic&#32

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. healthy subjects: (1) Ages among 18-65, healthy subjects; (2) Without any symptom of digestive tract such as acid regurgitation, heartburn, belching, nausea, vomiting, dysphagia, foreign body sensation of the pharynx, constipation, diarrhea, abdominal distention. 2. subjects with esophageal motility disorders: (1) Aged 18-65 years; (2) Conform to the Chicago Classification v3.0 by high resolution esophageal manometry. 3. subjects with functional dispepsia or chronic constipation: (1) Aged 18-65 years; (2) Conform to Rome III standards for functional GI diseases; 4. subjects with diabetic gastroparesis: (1) Aged 18-65 years; (2) with a history of chronic diabetics; (3) Conform to diagnostic standards for diabetic gastroparesis.

Exclusion criteria

Exclusion criteria: 1. healthy subjects (1) With any kinds of organic diseases; (2) Pregnant women, or with mental disorders. 2. subjects with esophageal motility disorders: (1) With any other kinds of serious organic diseases; (2) Pregnant women, or with mental disorders. 3. subjects with functional dispepsia or chronic constipation: (1) With any kinds of organic diseases; (2) Pregnant women, or with mental disorders. 4. subjects with diabetic gastroparesis: (1) With any other kinds of serious organic diseases; (2) Pregnant women, or with mental disorders.

Design outcomes

Primary

MeasureTime frame
Transit time of different segments of gastrointestinal tract in healthy individuals and patients with functional gastrointestinal diseases;Maximal speed of the capsule movement in different segments of GI tract in healthy subjects and patients with FGIDs;Mean speed of the capsuel movement in different segments of GI tract in healthy subjects and patients with FGIDs;Mean single forward movement length of the capsule in different segments of GI tract in healthy individuals and patients with FGIDs;Number of the backward and forward movement of the capsule in different segments of the GI tract in healthy subjects and patients with FGIDs;Maximal pressure of different segments of the GI tract in healthy subjects and patients with FGIDs;Minimal pressure of different segments of the GI tract in healthy subjects and patients with FGIDs;Mean pressure of different segments of the GI tract in healthy individuals and patients with FGIDs;Tolerance and adverse effect;

Secondary

MeasureTime frame
Endoscope image of different segments of GI tract in healthy individuals and FGIDs;

Countries

China

Contacts

Public ContactLiu Jun

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

liujun_99@126.com+86 027-85726602

Outcome results

None listed

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