A Double Blind, Randomised, placebo-contoled Trial to establish teh safety and efficacy of a probiotic in subjects with Irritable Bowel Syndrome - not available

• Conditions: Irritable bowel Syndrome

• Registration Number: EUCTR2009-015728-27-IE
• Lead Sponsor: Alimentary Health Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-09
• Last Update Posted: 14 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1.Be female and between 18 and 65 years of age;

2.Be able to give written informed consent;

3.Be willing to comply with the study requirements;

4.Be post-menopausal or, if of child-bearing potential, agree to use an adequate form of contraception (e.g., surgical sterilization, birth control pills, birth control implants, condoms AND spermicide, abstinence) as approved by the Investigator;

5.Be willing to refrain from taking any dietary supplements or other foods that contain fermented live bacteria during the study;

6.Be willing to refrain from taking any medications or preparations used in the therapy of IBS (herbal, dietary supplements, homeopathic preparations, etc.) during the study;

7.If using fiber supplements (e.g., Trifyba, Fybogel, Konsyl, Isogel, Regulan, Ispagel, Celevac, Normacol), the dose and regimen have remained stable for at least 30 days and the subject will continue the same dose and regimen throughout the length of the trial.

8.If using anti-depressants, the dose and regimen have remained stable for at least 90 days and the subject will continue the same dose and regimen throughout the length of the trial;

9.If using products that contain nicotine or caffeine, agrees to continue current usage levels throughout the length of the trial;

10.Have not participated in a clinical drug study or used an investigational new drug during the previous 30 days;

11.Be in generally good health as determined by the Investigator, except for IBS symptoms;

12.Have symptoms supportive of IBS: altered stool form, altered stool frequency, abnormal stool passage, passage of mucus, feeling of bloating or abdominal distension; and

13.Satisfy the essential features of the Rome III diagnostic criteria for IBS which are:
Recurrent abdominal pain or discomfort For at least 3 days/month in last 3 months associated with two or more of the following:
a.Improvement with defecation,
b.Onset associated with a change in frequency of stool,
c.Onset associated with a change in form [appearance] of stool.

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

1.Are pregnant or nursing (lactating) females;

2.Have IBS symptoms predominantly related to menstruation;

3.Have alarm symptoms suggestive of an underlying organic disease (weight loss, nocturnal symptoms, blood in stools, family history of colorectal cancer, relevant abnormalities on physical examinations, short duration of symptoms, progressive deterioration of symptoms, abnormal laboratory test, positive stool cultures in subjects with diarrhoea-predominant IBS or abnormalities on colonoscopy/sigmoidoscopy or abdominal ultrasound which require further investigation);

4.Have undergone prior gastrointestinal surgery (apart from appendectomy and hernia repair);

5.Subjects over 55 years of age who have not had a sigmoidoscopy/colonoscopy performed in the previous 5 years;

6.Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, immunological, etc.) or condition (excluding IBS) which, in the Investigator’s judgment, contraindicates administration of the study medication or participation in the study;

7.Have evidence of or history of t of malignancy (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected) within the previous five years;

8.Use of anti-psychotics in the prior three months;

9.Use of systemic steroids within the prior month;

10.Have a condition, or are taking a medication, that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results;

11.Have evidence of immunodeficiency;

12.Major psychiatric disorder (DSM-III-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse within the past 2 years;

13.Subject is participating in a psychological IBS treatment approach that was initiated within the past 6 months (behavioural therapy, hypnosis, etc);

14.Individuals who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial;

15.Subjects who were previously screened for participation in this study and failed to meet entry criteria.

16.Subjects who have had a previous cholescystectomy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified