Evaluating the Effectiveness of LACTOFOS in Constipated Patients (COSI)
|ClinicalTrials.gov Identifier: NCT01286376|
Recruitment Status : Unknown
Verified December 2010 by University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Dietary Supplement: Symbiotic Lactofos Dietary Supplement: Maltodextrin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double Blind, Comparative LACTOFOS With Placebo in Constipation Patients.|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||August 2011|
|Active Comparator: symbiotic||
Dietary Supplement: Symbiotic Lactofos
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
|Placebo Comparator: placebo||
Dietary Supplement: Maltodextrin
- Frequency of stool - Chart [ Time Frame: 30 days ]30 days taking 2 times per day. At morning and night
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286376
|Contact: Luciana Logulloemail@example.com|
|Contact: Dan Waitzberg, firstname.lastname@example.org|
|Ganep Nutrição Humana||Recruiting|
|São Paulo, Brazil, 01323-001|
|Contact: Luciana C. Logullo 55-11-32846318 email@example.com|
|Principal Investigator: Dan L. Waitzberg|
|Sub-Investigator: Luciana C. Logullo|
|Sub-Investigator: Maria de Lourdes T. Silva|
|Sub-Investigator: Juliana R. Martins|
|Sub-Investigator: Gláucia M. Shiroma|
|Sub-Investigator: Amanda F. Bittencourt|
|Principal Investigator:||Dan L. Waitzberg, phd||University of São Paulo|