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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Control placebo; Dietary Supplement: Probiotics

• Registration Number: NCT02108119
• Lead Sponsor: Probi AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Study Start: 2014-05-02
• Primary Completion: 2015-11-30
• Study Completion: 2015-11-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control placebo	Control placebo	-
Probiotics	Probiotics	-

Primary Outcome Measures

Name	Time	Method
Abdominal pain	28 days	0-10 numeric rating scale (NRS)

Trial Locations

Locations (1)

PreCare Trial & Recruitment; 🇳🇱 Beek, Netherlands