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A study on the application value of Linalotide capsules in colonoscopy bowel preparation

A study on the application value of Linalotide capsules in colonoscopy bowel preparation

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088166
Enrollment
Unknown
Registered
2024-08-13
Start date
2022-08-31
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

none

Interventions

observation group:3L of polyethylene glycol +linaclotide
control group:3L of polyethylene glycol
observation group:2L of polyethylene glycol + linaclotide

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Three FC sets:Inclusion criteria for subjects: 1. Meet the Rome ? criteria for FC diagnosis, with a Wexner Constipation Scale (WCS) score of 17-25 points; 2. Aged 18-75, regardless of gender; 3. Patients undergoing routine or anesthesia colonoscopy; 4. Voluntarily participate and sign a written informed consent form. Three NC sets:Inclusion criteria for subjects: 1. Aged 18-75, regardless of gender; 2. Patients undergoing routine or anesthesia colonoscopy; 3. Voluntarily participate and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: Three FC sets:1. History of serious heart, lung, liver, kidney diseases or cerebrovascular diseases within the past six months; 2. Clear history of colon polyps that have not been removed, colorectal cancer, or diarrhea (Bristol Stool Form Scale, BSFS stool consistency score of 6-7); 3. High-risk factors for intestinal preparation such as intestinal perforation, toxic megacolon, or intestinal obstruction; 4. Those who have taken laxatives, antidiarrheal medications, or other gastrointestinal motility drugs in the past two weeks; 5. History of gastrointestinal or pelvic surgery; 6. Pregnant and lactating women; 7. Allergy to the study drug. Three NC sets:1. A history of serious heart, lung, liver, kidney diseases, or cerebrovascular diseases within the past six months; 2. Clear history of constipation, colon polyps that have not been removed, colorectal cancer, or diarrhea (BSFS stool score of 6-7); 3. Risk factors for high-risk intestinal preparation, such as intestinal perforation, toxic megacolon, or intestinal obstruction; 4. Taking laxatives, anti-diarrheal drugs, or other gastrointestinal motility drugs in the past two weeks; 5. History of gastrointestinal or pelvic surgery; 6. Pregnant and lactating women; 7. Allergy to the study drug.

Design outcomes

Primary

MeasureTime frame
Bowel preparation therapy;Intestinal Preparation Compliance Rate;Incidence of adverse reactions;

Secondary

MeasureTime frame
The detection rate of polyps;Cecal intubation rate;The detection rate of adenomas;

Countries

China

Contacts

Public ContactZibin Tan

Affiliated Hospital of Qingdao University

m17685586889@163.com+86 186 6180 5123

Outcome results

None listed

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