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Evaluating the Effectiveness of LACTOFOS in Constipated Patients (COSI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286376
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ganep Nutrição Humana
Information provided by:
University of Sao Paulo
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 20, 2011
First Posted: January 31, 2011
Last Update Posted: January 31, 2011
Last Verified: December 2010

Keywords provided by University of Sao Paulo:
Symbiotics
Fiber
Constipation

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