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Evaluating the Effectiveness of LACTOFOS in Constipated Patients (COSI)

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. 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
Ganep Human Nutrition
Information provided by:
University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: Symbiotic Lactofos Dietary Supplement: Maltodextrin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Study Start Date : August 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Frequency of stool - Chart [ Time Frame: 30 days ]
    30 days taking 2 times per day. At morning and night

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01286376

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Contact: Luciana Logullo 55-11-32846318
Contact: Dan Waitzberg, phd 55-11-72662040

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Ganep Nutrição Humana Recruiting
São Paulo, Brazil, 01323-001
Contact: Luciana C. Logullo    55-11-32846318   
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 Human Nutrition
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Principal Investigator: Dan L. Waitzberg, phd University of São Paulo

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: SKL Functional Nutrition Identifier: NCT01286376     History of Changes
Other Study ID Numbers: COSI
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: December 2010
Keywords provided by University of Sao Paulo:
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms