Evaluating the Effectiveness of LACTOFOS in Constipated Patients (COSI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ganep Nutrição Humana
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01286376
First received: January 20, 2011
Last updated: January 28, 2011
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Constipation
Dietary Supplement: Symbiotic Lactofos
Dietary Supplement: Maltodextrin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Comparative LACTOFOS With Placebo in Constipation Patients.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Frequency of stool - Chart [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    30 days taking 2 times per day. At morning and night


Estimated Enrollment: 60
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: symbiotic Dietary Supplement: Symbiotic Lactofos
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
Other Names:
  • prebiotcs
  • probiotcs
Placebo Comparator: placebo Dietary Supplement: Maltodextrin
Maltodextrin
Other Name: Maltodextrin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Females aged 18-75 years
  2. A diagnosis of constipation defined by Rome III criteria
  3. Ability to good communication with the investigator and agreeing to requests from the entire study
  4. Patients must sign a formal consent to participate

Exclusion Criteria:

  1. Constipation drug source
  2. History or evidence of organic disease of the gastrointestinal tract such as tumors, inflammatory bowel disease, etc.. proven by radiological or endoscopic examination of the bowel (five years before and after onset of symptoms). If the investigator has doubts should request the necessary procedures, such as sigmoidoscopy, colonoscopy or edema bariatric to exclude organic disease
  3. History of laxative use which in the opinion of the investigator is consistent with severe laxative dependence
  4. Current History recent (12 months) of significant abuse of alcohol or drugs
  5. History of malignancy in 5 (five) previous years (except basal cell carcinoma treated well or cervical carcinoma in situ)
  6. Known history of cardiovascular control inappropriate and / or significant respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other illness which compromises the ability of patients to participate in the full study
  7. Use of investigational drugs in the previous month or intentional use of such drugs during the study
  8. Intention of regular use of other medications that affect intestinal motility and / or perceived
  9. Lactose malabsorption is not treatable. If clinical suspicion of lactose intolerance, the procedure for proper diagnosis should be made to establish or exclude a diagnosis. If malabsorption is diagnosed, the patient should receive appropriate conditions of treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286376

Contacts
Contact: Luciana Logullo 55-11-32846318 pesquisa@ganep.com.br
Contact: Dan Waitzberg, phd 55-11-72662040 pesquisa@ganep.com.br

Locations
Brazil
Ganep Nutrição Humana Recruiting
São Paulo, Brazil, 01323-001
Contact: Luciana C. Logullo    55-11-32846318    pesquisa@ganep.com.br   
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         
Sponsors and Collaborators
University of Sao Paulo
Ganep Nutrição Humana
Investigators
Principal Investigator: Dan L. Waitzberg, phd University of São Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SKL Functional Nutrition
ClinicalTrials.gov Identifier: NCT01286376     History of Changes
Other Study ID Numbers: COSI
Study First Received: January 20, 2011
Last Updated: January 28, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Symbiotics
Fiber
Constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014