Evaluating the Effectiveness of LACTOFOS in Constipated Patients

Launched by UNIVERSITY OF SAO PAULO · Jan 28, 2011

Keywords

ClinConnect Summary

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 s...

Gender

FEMALE

Eligibility 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