A randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and quality of life outcomes of Vi-Siblin in patients with low anterior resection syndrome following rectal cancer surgery.

Sykehuset Telemark HF4 个研究点分布在 1 个国家目标入组 120 人开始时间: 2026年6月1日最近更新: 2026年8月25日

试验速览

To determine the efficacy of Vi-Siblin on burden of symptoms as measured by LARS score

•Participant must be 18 ≥ years at the time of signing the informed concent
•Participants who report a LARS score >20 at 12 months or more post sphinchter-preserving surgery for rectal cancer (spontanous relieve can occur within the first year)
•Any temporary stoma must be reversed at least 3 months before inclusion
•Capable of giving signed informed concent as described in Appendix 1 in the protocoll
•Ability to take oral interventional compound

•Hypersensitivity to the active substance or to any of the excipients listed in section 6.
•in the SmPC (sucrose, sodium chloride).
•Difficulties swallowing or abnormal narrowing (stenosis) of the gastrointestinal tract, especially in the esophagus and cardia.
•Suspected or known intestinal obstruction.
•Intestinal paralysis or megacolon.
•Participants with the following rare, congenital medical conditions, are advised not to use Vi-Siblin and will therefore not be included in the study: inherited fructose intolerance, glucose-galactose malabsorption and sucrase-isomaltase deficiency.
•Diabetic patients receiving antidiabetic therapy, or patients treated with thyroid hormone-containing medicinal products must be excluded, unless they are under close clinical monitoring, as adjustments to these therapies may be required with concomitant use of the IMP.
•Prior or ongoing bowel regulatory treatment with similar effect on symptom reduction, including Vi-Siblin. Caution should also be made in case a participant use medicinal products known to inhibit intestinal peristalsis.
•Various conditions rendering the participant unable to answer questionnaires.

发起方

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Forskningsavdelingen

Scientific

Sykehuset Telemark HF

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