CIdiopathic chronic constipation MedDRA version: 8.1 Level: LLT Classification code 10010774 Term: Constipation
Conditions
Interventions
Pharmaceutical Form: Oral powder
INN or Proposed INN: Lactic acid producing organisms
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placeb
Sponsors
SOFAR SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18-70 aged patients - idiopathic chronic constipation, diagnosed with Rome II criteria - slow intestinal transit time - written informed consens Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - previous gastro-intestinal surgery - endocrine diseases - neurological and muscular diseases - treatment with drugs potentially able to modify intestinal motility - intolerance of study product - significative clinical diseases - malicious neoplasia - patient unreliability - pregnant women - previous partecipation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the symbiotic ability to improve the patient intestinal function and to reduce constipation;Secondary Objective: - to evaluate the ability to reduce intestinal transit time in constipated patients - to evaluate the quality of life - to verify the treatment tolerability;Primary end point(s): Not applicable | — |
Countries
Italy
Outcome results
None listed