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NCT04794049
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation
NA trial testing Lactulose in Colon Disease in 800 participants. Status unknown.
30 October 2021
Quick facts
| Lead sponsor | First People's Hospital of Hangzhou |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | screening |
| Enrollment | 800 |
| Start date | 1 May 2021 |
| Primary completion | 30 October 2021 |
| Estimated completion | 31 December 2021 |
Drugs / interventions tested
- Lactulose (LACTULOSE) — full drug profile →
- Polyethylene Glycol (PEG) — full drug profile →
Conditions studied
- Colon Disease — all drugs for Colon Disease →
Sponsor
First People's Hospital of Hangzhou
Who can join
Adults 18 to 80, any sex, with Colon Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost. Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04794049
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Currently open trials in the same condition.
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Other First People's Hospital of Hangzhou trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04794049 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First People's Hospital of Hangzhou
- Last refreshed: 11 March 2021
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