Constipation Clinical Trial
Official title:
Randomized, Double Blind, Comparative LACTOFOS With Placebo in Constipation Patients.
Determine the effectiveness of symbiotic LACTOFOS containing FOS and probiotics against placebo in patients with a diagnosis of constipation, comparing the average number of weekly evacuations in 2 (two) groups for 30 days.
A prospective, randomized, double blind, parallel group. Consist of a period of 30 days of
treatment with placebo or with LACTOFOS.Will study 120 patients were female with a diagnosis
of constipation according to Rome III criteria for at least 3 (three) months.
The experimental group (N = 60)will receive LACTOFOS 12g/day in two doses of 6 g. The
control group (N = 60)will receive a placebo (maltodextrin) from 12g/day in two shots of 6
g.
Subsequently, the patients will be classified according to the study of AGACHAN, which
determined a score based on the main complaints of patients. The symptoms that included
evaluation for the total score were stool frequency, difficulty / straining, pain at
defecation, feeling of incomplete evacuation, abdominal pain, time taken to initiate the
evacuation, type of assistance for evacuation, failed attempts / day and duration of
constipation. The intensity of each symptom varied within the range of 0 to 4, with the
exception of the item type of assistance for evacuation, which ranged from 0 to 2.
Constipation is classified as mild when the total sum of values (scores) vary from 00 to 10,
as moderate when the sum of the values obtained vary from 11 to 20 and severe when the final
sum range from 21 to 30.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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