Constipation
Conditions
Keywords
Symbiotics, Fiber, Constipation
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.
Interventions
DIETARY_SUPPLEMENTSymbiotic Lactofos
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
DIETARY_SUPPLEMENTMaltodextrin
Maltodextrin
Sponsors
Ganep Human Nutrition
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of stool - Chart | 30 days | 30 days taking 2 times per day. At morning and night |
Countries
Brazil
Contacts
Primary ContactLuciana Logullo
Backup ContactDan Waitzberg, phd
Outcome results
None listed