By InvitationPhase 4

Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy

China444 participantsStarted 2024-09-01

Plain-language summary

This is a single-center, single-blind, randomized controlled clinical study. Participants meeting the inclusion criteria were randomly assigned to lactulose + linaclotide group, lactulose group, and PEG group in equal proportion. In this study, the effectiveness, tolerability, adverse reactions and prognosis of three intestinal preparation regimens: lactulose -linalotide group, lactulose group and PEG group were compared by evaluating the intestinal cleanliness rate (BBPS score) of patients and quantitative analysis of intestinal bubble under colonoscopy, with a view to improving the intestinal cleanliness rate of colonoscopy subjects.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent;
✓. Age 18-80 years old, gender is not limited;
✓. The subjects could follow the follow-up plan, objectively describe the symptoms, and cooperate with the completion of the scale;
✓. Non-lactating pregnant women and no pregnancy plan during the test;
✓. Do not participate in any clinical trials for 3 months before and during the trial;

Exclusion criteria

✕. Presence of any contraindications to colonoscopy (gastrointestinal obstruction or perforation, severe acute inflammatory bowel disease, toxic megacolon, severe heart failure, renal failure, or liver failure, etc.)
✕. Patients with galactosemia;
✕. Pregnancy or lactation;
✕. Allergic to intestinal preparation drugs;
✕. Termination of the experiment for any other reason.

What they're measuring

Bowel preparation quality

Timeframe: 1 day of scheduled colonoscopy

Trial details

NCT IDNCT06748638

SponsorHaifeng Lan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Lactulose trials