Functional constipation
Conditions
Interventions
Gold Standard:AGIROMC radiopaque-marker (old version)
Index test:AGIROMC 
radiopaque-marker 
(new 
version)
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, gender is not limited; 2. Meet the diagnostic criteria of functional constipation in Rome IV, that is, the symptoms have been present for at least 6 months before the diagnosis, and the following diagnostic criteria have been met in the past 3 months, that is, 2 or more of the following must be included: (1) More than 25% of bowel movements feel labored; (2) More than 25% of the stools are dry balls or hard stools (Bristol stool character scale type 1-2); (More than 3025% of bowel movements have a feeling of incompleteness; (4) More than 25% of bowel movements have anorectal obstruction/blockage; (5) More than 25% of defecation requires manual assistance (such as assisting defecation with fingers, pelvic floor support) (6) Spontaneous defecation less than 3 times per week; (7) Loose stools rarely occur when laxatives are not used, and the diagnostic criteria for irritable bowel syndrome are not met. 3. Able and willing to comply with the taboos and restrictions specified in the program; 4. Subjects must be willing and able to fill out questionnaires and diaries; 5. Subjects can be followed up within the trial period in accordance with the provisions of the trial protocol; 6. Subjects agree to take contraceptive measures during the study; 7. The subjects understand the purpose and procedures of the trial and voluntarily participate in the trial, and voluntarily sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to barium; 2. Known or suspected organic lesions in the large intestine, i.e. obstruction, cancer or inflammatory disease; 3. Known or suspected gastrointestinal stenosis, obstruction, diverticulum, perforation, bleeding, infection; 4. The subject has severe and clinically uncontrolled cardiovascular, pulmonary, liver disease, neurological or psychiatric disease (including alcohol or drug abuse), cancer or AIDS, gastrointestinal or endocrine disease; 5. Women who are pregnant or breastfeeding; 6. Participated in other interventional clinical trials in the past three months; 7. Other circumstances judged by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistency rate of positive detection;Consistency rate of negative detection;Excretion rate of radiopaque markers;Colon transit time; | — |
Countries
China
Contacts
Public ContactHou Xiaohua
Huazhong University of Science and Technology
Outcome results
None listed