The Effect of Probiotics on Symptoms and Intestinal Flora in Patients With Irritable Bowel Syndrome

NCT ID: NCT02108119

Last Updated: 2017-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-02
• Study Completion Date: 2015-11-30

Brief Summary

To demonstrate benefit of a probiotic product in adults with irritable bowel syndrome.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotics

Group Type: ACTIVE_COMPARATOR

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Control placebo

Group Type: PLACEBO_COMPARATOR

Control placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Control placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Willing and able to provide informed consent
• Age ≥18 and ≤70 years at Visit 1
• IBS according to the Rome III criteria
• A score on abdominal pain NRS ≥3 and ≤6 at least two days a week measured the weeks before Visit 2 (baseline)
• IBS-SSS ≥75 and ≤300 at Visit 2 (baseline)
• Ability and willingness to understand and comply with the study procedures

Exclusion Criteria

• Known intolerance or allergy to milk products (protein or lactose) or gluten
• History of alcohol or substance abuse six months prior to screening
• Known Hepatitis B or C or Human Immunodeficiency Virus (HIV) 1 or 2
• Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
• Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the Investigator
• Other gastrointestinal disease(s) that explains the patient's symptoms, as judged by the Investigator
• Other severe disease(s) such as malignancy, severe coronary disease, kidney disease or neurological disease, as judged by the Investigator
• Symptoms indicating other severe disease(s) such as gastrointestinal bleeding, loss of weight or fever, as judged by the Investigator
• Severe psychiatric disease as judged by the Investigator
• Lack of suitability for participation in the study for any reason as judged by the Investigator
• Use of other probiotic products from Visit 1 and throughout the study.
• Consumption of antibiotic drugs 1 month prior to screening and throughout the study.
• Consumption of drugs on a regular basis which could interfere with symptom evaluation as judged by the Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Probi AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PreCare Trial & Recruitment

Beek, , Netherlands

Countries

Netherlands

Other Identifiers

PRO008

Identifier Type: -

Identifier Source: org_study_id