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

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

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Control placebo

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Beek, Netherlands, 6191
    • PreCare Trial & Recruitment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics	Dietary supplement: Probiotics
Placebo Comparator: Control placebo	Dietary supplement: Control placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal pain	0-10 numeric rating scale (NRS)	28 days

Collaborators and Investigators

• Sponsor: Probi AB

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2014
• Primary Completion (Actual): November 30, 2015
• Study Completion (Actual): November 30, 2015

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: PRO008