Functional Constipation
Conditions
Brief summary
A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.
Detailed description
Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.
Interventions
DRUGlactobacillus reuteri
Lactobacillus reuteri (DSM 17938) was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks
DRUGplacebo
a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
Sponsors
Catholic University, Italy
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* functional constipation rome III
Exclusion criteria
* hypothyroidism or other metabolic or renal abnormalities, or * antibiotic's treatment, * probiotic or prebiotic supplementation in the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The increase of BMs/week frequency | January to June 2012 (up to 6 months) |
Secondary
| Measure | Time frame |
|---|---|
| the improvement of stool consistency | january to june 2012 (up to 6 months) |
Countries
Italy
Outcome results
None listed