The aim of the study is to show that new polyethylene glycol (PEG) solution without electrolytes is as effective in the treatment of constipation as PEG solution with electrolytes in the elderly institutionalized people. Also, the tolerability and the safety of the study drug will be examined.
Constipation is a major problem in elderly institutionalised patients. Non-pharmacological treatments are proposed as primary management of constipation, but institutionalised patients are not likely to be able to increase either the intake of dietary fibre or fluid and their physical activity is low. The latest agent widely used for the treatment of constipation is polyethylene glycol (PEG). PEG is classified into the group of osmotic laxatives. It is minimally absorbed from the gastrointestinal tract and not metabolised by colonic bacteria. Most of the PEG products at the market contain electrolytes and have a salty and unpleasant taste which may affect the compliance of using them. A PEG solution without electrolytes has been developed and used for some years in various countries. Now we will compare the efficacy and safety of PEG solutions with or without electrolytes and their acceptability in the use for constipation in institutionalised patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
powder for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
granules for oral solution 12 g of PEG once a day, twice a day or once every other day for 4 weeks
Koskikoti
Tampere, Finland
Koivupirtti
Tampere, Finland
Tampereen sotainvalidien Veljeskoti
Tampere, Finland
Lahdensivun koti
Tampere, Finland
Stool frequency
Time frame: week 4
Stool frequency
Time frame: Week 2
Stool straining
Time frame: Weeks 2 and 4
Stool consistency
Time frame: Weeks 2 and 4
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