The Effect of Melatonin in Patients With Low Anterior Resection Syndrome

Phase 2 Unknown 21 enrolled Ismail Gögenur Aarhus University Hospital · collab Hvidovre University Hospital · collab

RandomizedCrossoverQuadruple-blindTreatment

Summary

The primary objective of the study is to investigate whether treatment with melatonin has an alleviating effect on Low Anterior Resection Syndrome (LARS) symptoms. Secondarily, the effect of the treatment on bowel movements, other patient reported symptoms, quality of life, depression, anxiety, sleep disturbances, motilin levels, and microscopic changes in rectal mucosa will be investigated.

Timeline

Start: 2021-10-13
Primary completion: 2023-12
Completion: 2023-12

Publications

Zahid JA, Madsen MT, Bulut O, Christensen P, Gogenur I. Effect of melatonin in patients with low anterior resection syndrome (MELLARS): a study protocol for a randomised, placebo-controlled, crossover trial. BMJ Open. 2023 Sep 11;13(9):e067763. doi: 10.1136/bmjopen-2022-067763.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Melatonin	Small molecule	25 mg	Rectal

Indications

No indication recorded.