Efficacy of Probiotics on Excessive Gas Accumulation
Primary Purpose
Flatulence, Bloating
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Probiotic supplement
Placebo supplement
Sponsored by
About this trial
This is an interventional prevention trial for Flatulence
Eligibility Criteria
Inclusion Criteria:
- Healthy adults 18-50 years, at the time of signing the informed consent.
- Willing and able to give written informed consent for participating in the study
- Willing to comply with all study procedures
Exclusion Criteria:
- Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
- Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
- Known gluten intolerance, lactose intolerance, milk protein allergy
- Vegetarian diet
- Intake of antibiotics within four weeks prior to the start of the study
- Hypersensitivity to any of the ingredients in the investigational product (IP)
- Regular intake of probiotics within four weeks prior to the start of the study
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
- Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Sites / Locations
- Lund University
- CTC Clinical Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotics
Placebo
Arm Description
Intake of a probiotic capsule once daily
Intake of a placebo capsule once daily
Outcomes
Primary Outcome Measures
Breath hydrogen
The level of breath hydrogen is measured after a challenge with lactulose
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03134469
Brief Title
Efficacy of Probiotics on Excessive Gas Accumulation
Official Title
Efficacy of Probiotics on Excessive Gas Accumulation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
October 19, 2017 (Actual)
Study Completion Date
October 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy of probiotics on excessive gas accumulation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatulence, Bloating
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Intake of a probiotic capsule once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intake of a placebo capsule once daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic supplement
Intervention Description
Probiotic supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo supplement
Intervention Description
Placebo supplement
Primary Outcome Measure Information:
Title
Breath hydrogen
Description
The level of breath hydrogen is measured after a challenge with lactulose
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults 18-50 years, at the time of signing the informed consent.
Willing and able to give written informed consent for participating in the study
Willing to comply with all study procedures
Exclusion Criteria:
Chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
Known gluten intolerance, lactose intolerance, milk protein allergy
Vegetarian diet
Intake of antibiotics within four weeks prior to the start of the study
Hypersensitivity to any of the ingredients in the investigational product (IP)
Regular intake of probiotics within four weeks prior to the start of the study
History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Facility Information:
Facility Name
Lund University
City
Lund
Country
Sweden
Facility Name
CTC Clinical Consultants
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Probiotics on Excessive Gas Accumulation
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