A symbiotic for the treatment of functional constipation - nath1/2008

Conditions: Functional crhonic constipation
MedDRA version: 9.1Level: LLTClassification code 10063582Term: Constipation chronic

Registration Number: EUCTR2008-000913-30-IT

Lead Sponsor: ATHURA SR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

.obtaining the informed consense, .age >18 and <65 .Patients, for 3 years, fulfilling the Rome III criteria for Functional Constipation with/without obstructed defecation according Rome III criteria.Patients will be randomised in two groups assigned to either of the following treatment protocols. .A patological intestinal transit time evaluated with Metcalf e coll. methods over the normal range of 60 Hours for the ♂ and 70 hours per le ♀.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

.age >65 or <18 years .have symptoms, particularly abdominal pain/disconfort, that are, according Rome III criteria, justified to an subtipe of IBS symptoms .the patients before 2 years had abdominal and proctological surgery, excluded appendectomy, hysterectomy, rubber band ligation and doppler band ligation. .at defecography the patients have a rectocele > 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 .