Evaluating the Effectiveness of LACTOFOS in Constipated Patients
NCT ID: NCT01286376
Last Updated: 2011-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2010-08-31
2011-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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symbiotic
Symbiotic Lactofos
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
placebo
Maltodextrin
Maltodextrin
Interventions
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Symbiotic Lactofos
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
Maltodextrin
Maltodextrin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
FEMALE
No
Sponsors
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Ganep Human Nutrition
OTHER
University of Sao Paulo
OTHER
Responsible Party
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SKL Functional Nutrition
Principal Investigators
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Dan L. Waitzberg, phd
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Ganep Nutrição Humana
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Luciana C. Logullo
Role: primary
References
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Waitzberg DL, Logullo LC, Bittencourt AF, Torrinhas RS, Shiroma GM, Paulino NP, Teixeira-da-Silva ML. Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. Clin Nutr. 2013 Feb;32(1):27-33. doi: 10.1016/j.clnu.2012.08.010. Epub 2012 Aug 23.
Other Identifiers
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COSI
Identifier Type: -
Identifier Source: org_study_id