Ignite Creation Date:
2024-05-05 @ 11:14 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01286376
Status:
UNKNOWN
Last Update Posted:
2011-01-31
First Post:
2011-01-20
Brief Title:
Evaluating the Effectiveness of LACTOFOS in Constipated Patients
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Randomized Double Blind Comparative LACTOFOS With Placebo in Constipation Patients
Status:
UNKNOWN
Status Verified Date:
2010-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSI
Brief Summary:
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
Detailed Description:
A prospective randomized double blind parallel group Consist of a period of 30 days of treatment with placebo or with LACTOFOSWill 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 60will receive LACTOFOS 12gday in two doses of 6 g The control group N 60will receive a placebo maltodextrin from 12gday 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
The experimental group N 60will receive LACTOFOS 12gday in two doses of 6 g The control group N 60will receive a placebo maltodextrin from 12gday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None