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Completed

NCT Number: NCT05291325

Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy

The clinical purpose of this study was to investigate whether the adjuvant application of linaclotide in bowel preparation for colonoscopy could improve the quality of bowel preparation or reduce the dosage of laxatives.

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Key information

Conditions

Bowel Preparation for Colonoscopy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Naval Medical University

Shanghai, 200433, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years old, male or female;
  • To undergo diagnostic, screening or monitoring colonoscopy;
  • Signed written informed consent;

Exclusion criteria

  • Severe cardiopulmonary insufficiency, renal failure or a history of stroke or myocardial infarction within six months;
  • History of abdominal or pelvic surgery;
  • Pregnant and lactating women;
  • BMI > 28, BMI < 18.5, inflammatory bowel disease, constipation (defecation less than 3 times in the last week, and laborious defecation, fecal sclerosis, low volume) or intestinal obstruction and other high-risk factors of intestinal preparation;
  • Abnormal coagulation function or taking antiplatelet or anticoagulant drugs within 7 days;
  • Warning symptoms and signs of colorectal cancer: hematochezia, melena, unexplained anemia, low body weight, abdominal mass, positive digital rectal test; or imaging and laboratory tests highly suspect colorectal cancer;
  • Colon polyps have been identified;
  • Stow score 7 (watery, no solid mass), diarrhea was considered;
  • Participation in other interventional clinical trials within 60 days.

Treatment and study plan

3L PEG + Linaclotide

Drug

Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.

3L PEG

Drug

Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.

2L PEG + Linaclotide

Drug

Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1000ml polyethylene glycol electrolyte solution within 1 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.

Primary outcomes

  1. Bowel preparation adequate rate

    Time frame: within 10 minute after viewing colonoscopy video.

    The proportion of participants with all colon segment scores (right colon, transverse colon, left colon) were ≥ 2 according to Boston Bowel Preparation Scale (BBPS) .

Secondary outcomes

  1. Boston bowel preparation scale score

    Time frame: Within 10 minute after viewing colonoscopy video.

    The BBPS scoring rules: 0, unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1, portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid; 2, minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well; 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. the higher the score, the better the quality of bowel preparation. 3 intestinal segments were scored separately: the right side of the colon, the transverse section of the colon, and the left side of the colon. Total BBPS score 0-9, the higher the score, the better the quality of bowel preparation.

  2. Aronchick Scale

    Time frame: Within 10 minute after viewing colonoscopy video.

    Overall bowel preparation was scored prior to irrigation or suction. The Aronchick Scale scoring rules: 1, excellent, a small amount of liquid, 95% mucous membrane is visible; 2, good, plenty of clear fluid, covering 5%-25% of mucous membrane, 90% mucous membrane is visible; 3, medium, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 4, poor, semi-solid manure that cannot be sucked out or washed away, 90% mucous membrane is visible; 5, inadequate, repeated bowel preparation or reexamination is required. Total Aronchick score 1-5, the lower the score, the better the quality of bowel preparation.

  3. Bowel preparation excellent rate

    Time frame: Within 10 minute after viewing colonoscopy video.

    The proportion of participants with total score ≥ 8 according to Boston Bowel Preparation Scale.

  4. Bowel preparation completion rate assessed by questionnaire survey

    Time frame: Immediately after questionnaire survey.

    Proportion of subjects with laxative intake greater than 90% of the required amount in protocol.

  5. Subjects satisfaction rate assessed by questionnaire survey

    Time frame: Immediately after questionnaire survey.

    Proportion of subjects satisfacted with the whole intestinal preparation process. Subjects satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied.

  6. Endoscopists satisfaction with the quality of bowel preparation

    Time frame: Immediately after colonoscopy.

    Proportion of endoscopists satisfacted with the quality of bowel preparation during colonoscopy. Endoscopists satisfaction was divided into four grades: 4, very satisfied; 3, moderately satisfied; 2, moderately dissatisfied; 1, very dissatisfied. Subjects in grades 3 and 4 were considered satisfied; subjects in grades 1 and 2 were considered dissatisfied.

  7. Adenoma detection rate

    Time frame: 14 days after colonosopy.

    The adenoma detection rate was calculated as the number of colonoscopies with at least one adenoma detected divided by the total number of colonoscopies in the group. Adenomatous polyps must be confirmed by pathological findings.

  8. Polyp detection rate

    Time frame: Immediately after colonoscopy.

    The polyp detection rate was calculated as the number of colonoscopies with at least one polyp detected divided by the total number of colonoscopies in the group.

  9. Incidence of adverse events assessed by questionnaire survey

    Time frame: Immediately after questionnaire survey.

    Proportion of subjects with adverse events occuring in intestinal preparation.

  10. Drug compliance in linaclotide group

    Time frame: Immediately after questionnaire survey.

    Proportion of subjects Taking 3 linaclotide capsules according to the protocol in linaclotide group.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • 900th Hospital of PLA Joint Logistic Support Force
  • Affiliated Hospital of Qinghai University
  • Affiliated Hospital of Southwest Medical University
  • Affiliated Yueqing Hospital of Wenzhou Medical University
  • Daping Hospital of Army Medical University
  • General Hospital of Ningxia Medical University
  • Huizhou Municipal Central Hospital
  • Qilu Hospital of Shandong University
  • Ruijin Hospital
  • Second Xiangya Hospital of Central South University
  • Seventh Medical Center of PLA Army General Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Zhongshan Hospital
  • Shanxi Provincial People's Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Nanchang University
  • The First Affiliated Hospital of Soochow University
  • The First Hospital of Jilin University
  • The First Hospital of Shihezi University
  • The First People's Hospital of Yunnan
  • The Second Affiliated Hospital of Air Force Military Medical University
  • The Second Affiliated Hospital of Dalian Medical University
  • The Second Hospital of Hebei Medical University
  • The Third Affiliated Hospital of Wenzhou Medical University
  • Zunyi Medical College

Registry information

Official study title

Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy: a Multicenter, Randomized, Controlled Clinical Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 22, 2022
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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