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A randomized clinical trial to evaluate the efficacy of polyethylene glycol vs psyllium fiber to prevent rebleeding in patients hospitalized with bleeding diverticular disease.

A randomized clinical trial to evaluate the efficacy of polyethylene glycol vs psyllium fiber to prevent rebleeding in patients hospitalized with bleeding diverticular disease. - Prevention of rebleeding in diverticular disease.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52735
Enrollment
260
Registered
2020-07-13
Start date
2022-05-16
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Bleeding Diverticular disease

Interventions

Group A: polyethylene glycol (OTC) twice daily, for the period of 12 weeks. Group B: psyllium fiber (OTC) twice daily, for the period of 12 weeks.

Sponsors

Elisabeth-Tweesteden ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients between the ages of 18 or older. Patients who are hospitalized for bleeding diverticular disease in het ETZ. Patients with diverticular disease based on colonoscopy, sigmoïdscopy or CT-scan

Exclusion criteria

Exclusion criteria: Other bleeding diseases of the colon requiring medicinal treatment such as IBD or infection Surgical treatment following initial episode of bleeding diverticular disease. Patients using polyethylene glycol or psyllium fiber regularly, more than twice daily. Patients who are pregnant, lactating or planning pregnancy while enrolled in the study. Patients who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject*s safety or confound data interpretation

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the difference in incidence of rebleeding measured by preformatted questionnaire and clinical data between the polyethylene glycol vs psyllium fiber group.

Secondary

MeasureTime frame
The secondary endpoints of the study are the differences in quality of live indicated by the EuroQol questionnaire, stool frequency and - consistency measured by the Bristol Stool Scale and diverticular disease activity measured by standard clinical and laboratory assessments.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)