Vi-Siblin for LARS: A randomized, controlled trial.

Prior treatment

• 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.

Other illness

• Various conditions rendering the participant unable to answer questionnaires.

Lab values

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. in the SmPC (sucrose, sodium chloride).
• 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.

Other

• 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.

• Participant must be 18 ≥ years at the time of signing the informed concent
• Participants who report a LARS score >20 at 6 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