Evaluating the Effectiveness of LACTOFOS in Constipated Patients (COSI)
Primary Purpose
Constipation
Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Symbiotic Lactofos
Maltodextrin
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Symbiotics, Fiber, Constipation
Eligibility Criteria
Inclusion Criteria:
- Females aged 18-75 years
- A diagnosis of constipation defined by Rome III criteria
- Ability to good communication with the investigator and agreeing to requests from the entire study
- Patients must sign a formal consent to participate
Exclusion Criteria:
- Constipation drug source
- 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
- History of laxative use which in the opinion of the investigator is consistent with severe laxative dependence
- Current History recent (12 months) of significant abuse of alcohol or drugs
- History of malignancy in 5 (five) previous years (except basal cell carcinoma treated well or cervical carcinoma in situ)
- 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
- Use of investigational drugs in the previous month or intentional use of such drugs during the study
- Intention of regular use of other medications that affect intestinal motility and / or perceived
- 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
Sites / Locations
- Ganep Nutrição HumanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
symbiotic
placebo
Arm Description
Outcomes
Primary Outcome Measures
Frequency of stool - Chart
30 days taking 2 times per day. At morning and night
Secondary Outcome Measures
Full Information
NCT ID
NCT01286376
First Posted
January 20, 2011
Last Updated
January 28, 2011
Sponsor
University of Sao Paulo
Collaborators
Ganep Human Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT01286376
Brief Title
Evaluating the Effectiveness of LACTOFOS in Constipated Patients
Acronym
COSI
Official Title
Randomized, Double Blind, Comparative LACTOFOS With Placebo in Constipation Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Ganep Human Nutrition
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Symbiotics, Fiber, Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
symbiotic
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Symbiotic Lactofos
Other Intervention Name(s)
prebiotcs, probiotcs
Intervention Description
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin
Primary Outcome Measure Information:
Title
Frequency of stool - Chart
Description
30 days taking 2 times per day. At morning and night
Time Frame
30 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females aged 18-75 years
A diagnosis of constipation defined by Rome III criteria
Ability to good communication with the investigator and agreeing to requests from the entire study
Patients must sign a formal consent to participate
Exclusion Criteria:
Constipation drug source
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
History of laxative use which in the opinion of the investigator is consistent with severe laxative dependence
Current History recent (12 months) of significant abuse of alcohol or drugs
History of malignancy in 5 (five) previous years (except basal cell carcinoma treated well or cervical carcinoma in situ)
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
Use of investigational drugs in the previous month or intentional use of such drugs during the study
Intention of regular use of other medications that affect intestinal motility and / or perceived
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Logullo
Phone
55-11-32846318
Email
pesquisa@ganep.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Waitzberg, phd
Phone
55-11-72662040
Email
pesquisa@ganep.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan L. Waitzberg, phd
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ganep Nutrição Humana
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana C. Logullo
Phone
55-11-32846318
Email
pesquisa@ganep.com.br
First Name & Middle Initial & Last Name & Degree
Dan L. Waitzberg
First Name & Middle Initial & Last Name & Degree
Luciana C. Logullo
First Name & Middle Initial & Last Name & Degree
Maria de Lourdes T. Silva
First Name & Middle Initial & Last Name & Degree
Juliana R. Martins
First Name & Middle Initial & Last Name & Degree
Gláucia M. Shiroma
First Name & Middle Initial & Last Name & Degree
Amanda F. Bittencourt
12. IPD Sharing Statement
Citations:
PubMed Identifier
22959620
Citation
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.
Results Reference
derived
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Evaluating the Effectiveness of LACTOFOS in Constipated Patients
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