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
Sponsored by
About this trial
This is an interventional prevention trial for Irritable Bowel Syndrome
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.
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
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
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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