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

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Probiotics

Control placebo

About this trial

This is an interventional prevention trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

PreCare Trial & Recruitment

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotics

Control placebo

Arm Description

Outcomes

Primary Outcome Measures

Abdominal pain

0-10 numeric rating scale (NRS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02108119

First Posted

April 1, 2014

Last Updated

June 15, 2017

Sponsor

Probi AB

1. Study Identification

Unique Protocol Identification Number

NCT02108119

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

May 2, 2014 (Actual)

Primary Completion Date

November 30, 2015 (Actual)

Study Completion Date

November 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Probi AB

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probiotics

Arm Type

Active Comparator

Arm Title

Control placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotics

Intervention Type

Dietary Supplement

Intervention Name(s)

Control placebo

Primary Outcome Measure Information:

Title

Abdominal pain

Description

0-10 numeric rating scale (NRS)

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

PreCare Trial & Recruitment

City

Beek

ZIP/Postal Code

6191

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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