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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134469
Other study ID # ProGastro 17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2017
Est. completion date October 19, 2017

Study information

Verified date September 2018
Source Probi AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy of probiotics on excessive gas accumulation


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date October 19, 2017
Est. primary completion date October 19, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic supplement
Probiotic supplement
Placebo supplement
Placebo supplement

Locations

Country Name City State
Sweden Lund University Lund
Sweden CTC Clinical Consultants Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Breath hydrogen The level of breath hydrogen is measured after a challenge with lactulose 4 hours
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