Evaluating the Effectiveness of LACTOFOS in Constipated Patients

Constipation Clinical Trial

— COSI  

Official title:

Randomized, Double Blind, Comparative LACTOFOS With Placebo in Constipation Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01286376
• Other study ID #: COSI
• Status: Recruiting
• Phase: Phase 3
• First received: January 20, 2011
• Last updated: January 28, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: December 2010
• Source: University of Sao Paulo
• Contact: Luciana Logullo
• Phone: 55-11-32846318
• Email: pesquisa[@]ganep.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Symbiotic Lactofos
Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
• Maltodextrin
Maltodextrin

Locations

Country	Name	City	State
Brazil	Ganep Nutrição Humana	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Ganep Nutrição Humana

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of stool - Chart	30 days taking 2 times per day. At morning and night	30 days	Yes