search
Back to results

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
Probi AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Flatulence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 26, 2017
Last Updated
September 24, 2018
Sponsor
Probi AB
search

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

We'll reach out to this number within 24 hrs