Efficacy of Probiotics on Excessive Gas Accumulation

Bloating Clinical Trial

Official title:

Efficacy of Probiotics on Excessive Gas Accumulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134469
• Other study ID #: ProGastro 17
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Bloating
• Flatulence

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