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The effects of combined use of linaclotide and oral sulfate solution in bowel preparation for chronic constipation patients undergoing colonoscopy

The effects of combined use of linaclotide and oral sulfate solution in bowel preparation for chronic constipation patients undergoing colonoscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096394
Enrollment
Unknown
Registered
2025-01-22
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Chronic constipation

Interventions

Test group1:(1) take 1d-linaclotide at 7AM on the day before the procedure, (2)ingested diluted OSS followed by 1L water on the night before the procedure starting at 7 PM, OSS were dissolved in appro
Test group2: (1) take 1d-linaclotide at 7AM two days before the procedure, (2) 1d-linaclotide at 7AM on the day before the procedure, (3) ingested diluted OSS followed by 1L water on the night before
Control group:ingested diluted OSS followed by 1L water on the night before the procedure starting at 7 PM, OSS were dissolved in approximately by 500ml water, and (2) drink 500mL diluted OSS and 1L w

Sponsors

Beijing Shijitan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years old; (2) Diagnosis of chronic constipation according to Rome IV criteria must include 2 or more of the following: at least 25% of bowel movements are laborious; At least 25% of bowel movements are dry bulb or hard stool; At least 25% of bowel movements are incomplete; At least 25% of bowel movements have anorectal obstruction and/or blockage; At least 25% of bowel movements require manual assistance, and spontaneous bowel movements < 3 times a week. Loose stools are rare when laxatives are not used. Does not meet diagnostic criteria for irritable bowel syndrome. (3) voluntarily signed written informed consent, including consent to the screening process conducted for the purpose of determining eligibility; (4) The patient can communicate well with the investigator and be able to complete the trial in accordance with the protocol; (5) Can take intestinal cleansing drugs correctly according to the requirements of the project; (6) Follow-up on time.

Exclusion criteria

Exclusion criteria: (1) No indication for full colonoscopy; (2) There are general contraindications to bowel preparation, such as gastrointestinal obstruction, toxic megacolon, surgical acute abdomen including appendicitis, intestinal perforation, acute diverticulitis, etc.; (3) Presence of one of the following diseases: electrolyte disorders, severe heart, liver and kidney diseases, coagulation dysfunction; (4) Have a history of colon surgery; (5) Patients who have taken or previously taken linaclotide or are known to be allergic to linaclotide; (6) Those who are pregnant or plan to become pregnant during the study as determined by pregnancy test; (7) lactating women; (8) Is participating in other clinical observational trials or has participated in other clinical trials within 60 days.

Design outcomes

Primary

MeasureTime frame
Quality of bowel preparation;

Secondary

MeasureTime frame
Defecation frequency;Caecal intubation rate;Interval between the first OSS and the first defecation;Adenoma detection rate;Colonoscope insertion time and withdrawal time;

Countries

China

Contacts

Public ContactChunmei Guo

Beijing Shijitan Hospital, Capital Medical University

guoguo10086@163.com+86 134 2647 1832

Outcome results

None listed

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