Clinical trial NCT01286376: Evaluating the Effectiveness of LACTOFOS in Constipated Patients
Official title: Randomized, Double Blind, Comparative LACTOFOS With Placebo in Constipation Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Constipation
Keywords: Symbiotics
Fiber
Constipation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Ganep Human Nutrition
First posted: 2011-01-31
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of stool - Chart
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Ganep Nutrição Humana
Study officials:
affiliation: University of Sao Paulo
name: Dan L. Waitzberg, phd
role: PRINCIPAL_INVESTIGATOR
References:
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.