EFFICACY OF ORAL SODIUM CROMOGLICATE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME: A MULTI-CENTRE, RANDOMIZED, GROUP COMPARATIVE, DOUBLE -BLIND, PLACEBO CONTROLLED STUDY

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

1- Age >18 years and < 80 years
2- Positive diagnosis for IBS, established in conformity to ROMA II criteria on the basis of presence of pain or discomfort for at least 12 weeks in the last year with at least two of the following characteristics: a) attenuated stools and b) associated initially with variation in the stool frequency; c) associated initially with stool consistency variations.
3- Lack of predominant symptoms of dyspepsia and/or GERD.
4-If female, should be infertile ( post menopause or because of surgery) or, if fertile, requested to use a valid contraceptive system and undergo to the pregnancy test that must give negative response at the time of enrolment.
5- If female, must not be breastfeeding
6- Good general health on the basis of the anamnesis, objective examination, laboratory tests. Subjects with food intolerance or bacterial contamination of the intestine not adequately responsive to therapy.
7- Rectal sigmoidoscopy with two biopsies of the colic mucosa of the descending colon.
8- Patients’ written informed consent, approved by the local Ethic Committee before the start of any study procedure.

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

Patients wil be excluded from the study on the basis of the following conditions:
1-Abdominal surgery ( exception made for hysterectomy, caesarean appendicectomy, colecistectomy, plastic surgery for inguinal hernia.
2-Recent history ( previous six months ) of drug and alcohol abuse.
3-Recent intake ( previous 4 months) of test medication.
4-Concomitant use of medications that influence gastrointestinal functions ( anti-cholinergic, spasmolytics, pro-kinetics, anti-diarrhoeal, opium derivatives, laxatives), as well as antidepressant and serotonin agonists and antagonists.
5-Presence of cardiac, renal, neurological, psychiatric, neoplastic, endocrine, methabolic diseases.
6-Proven or suspected neoplastic pathology with the exception of basal carcinoma or skin squamous cells type , adequately treated.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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