ISPAGHULA HUSK for Low anterior resection syndrome (LARS) after rectal cancer surgery | History of rectal cancer

Inclusion criteria

• {"criterion_text":"- Participant must be 18 ≥ years at the time of signing the informed concent"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Any temporary stoma must be reversed at least 3 months before inclusion"}
• {"criterion_text":"- Capable of giving signed informed concent as described in Appendix 1 in the protocoll"}
• {"criterion_text":"- Ability to take oral interventional compound"}

Exclusion criteria

• {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. in the SmPC (sucrose, sodium chloride)."}
• {"criterion_text":"- Difficulties swallowing or abnormal narrowing (stenosis) of the gastrointestinal tract, especially in the esophagus and cardia."}
• {"criterion_text":"- Suspected or known intestinal obstruction."}
• {"criterion_text":"- Intestinal paralysis or megacolon."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Various conditions rendering the participant unable to answer questionnaires."}

Primary endpoints

• {"endpoint_text":"- Total LARS score 8 weeks after start of treatment","definition_or_measurement_approach":"Total LARS score measured using the LARS questionnaire 8 weeks after treatment start (burden of symptoms as measured by LARS score)."}

Secondary endpoints

• {"endpoint_text":"- HRQoL scores 8 weeks after start of treatment","definition_or_measurement_approach":"Health-related quality of life scores measured 8 weeks after start of treatment (overall and organ-specific HRQoL as described in objectives)."}
• {"endpoint_text":"- Time (in weeks) from initiation of treatment to first clinically relevant improvement in LARS score","definition_or_measurement_approach":"Measured in weeks from treatment initiation to first clinically relevant improvement in LARS score."}
• {"endpoint_text":"- LARS scores and its items at baseline and after 8 weeks of treatment","definition_or_measurement_approach":"LARS total score and individual item scores assessed at baseline and at 8 weeks after start of treatment."}

Norway

Earliest CTIS Part Ii Submission Date

16-04-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

11

Number Of Sites

4

Number Of Participants

120

Primary sponsor

Full Name

Sykehuset Telemark HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"South-Eastern Norway Regional Health Authority","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Kragerø Tablettfabrikk AS","duties_or_roles":"Monetary support","organisation_type":""}