Functional crhonic constipation MedDRA version: 9.1 Level: LLT Classification code 10063582 Term: Constipation chronic
Conditions
Interventions
Product Name: Ispaghula, combinations
Pharmaceutical Form: Oral powder
INN or Proposed INN: Ispaghula, combinations
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Ph
Sponsors
NATHURA SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: .obtaining the informed consense, .age >18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: .age >65 or 3 cm and/or a complete rectal prolapse[Dvorkin LS et al. Br J Surg 2005; 92: 866-72) .at proctological evaluation have a mucosal prolapse of third degree according Parks classification and/or anal fissures. .the patiens take on drugs promoting constipation that are not suspensible (calciumantagonists, nitroderivates,etc .presenting a patological results above 80% of the psycometric itemsabout illness behaviour: CES-D,SCL-90-R,IBQ .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the effect of a symbiotic a mixture of hyspaghula husk powder 2gr, plantago ovata variety, 99% of purity, and a mix of Lactobacillus acidophilus, plantarum, rhamnosus ? Bifidobacterium breve, longum for the treatment of chronic constipation due to colonic and rectal disfunction.;Secondary Objective: To evaluate: a)the reduction of the severity score index of constipation on the base of Agachan-Wexner score (DisColonRectum 1996; 39: 681-5) b)the improvement of the QoL evaluated with a specific questionnaire for the Functional disorders (Dig Dis Sci 1998; 43: 400-11).;Primary end point(s): The improvement of the intestinal transit time, the frequency and the normalization of the evacuation rithms and fecal consistence according the Bristol Form scale. | — |
Countries
Italy
Outcome results
None listed