Efficacy of Probiotics on Excessive Gas Accumulation

Not Applicable

Completed

• Conditions: Flatulence; Bloating
• Interventions: Dietary Supplement: Probiotic supplement; Dietary Supplement: Placebo supplement

• Registration Number: NCT03134469
• Lead Sponsor: Probi AB

Brief Summary

Efficacy of probiotics on excessive gas accumulation

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-26
• Study First Posted: 2017-05-01
• Primary Completion: 2017-10-19
• Study Completion: 2017-10-19
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-24
• Last Update Posted: 2018-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotics	Probiotic supplement	Intake of a probiotic capsule once daily
Placebo	Placebo supplement	Intake of a placebo capsule once daily

Primary Outcome Measures

Name	Time	Method
Breath hydrogen	4 hours	The level of breath hydrogen is measured after a challenge with lactulose

Trial Locations

Locations (2)

Lund University; 🇸🇪 Lund, Sweden

CTC Clinical Consultants; 🇸🇪 Uppsala, Sweden