Efficacy of Probiotics on Excessive Gas Accumulation

Efficacy of probiotics on excessive gas accumulation

Study Overview

• Status: Completed
• Conditions: Flatulence; Bloating
• Intervention / Treatment: Dietary supplement: Probiotic supplement; Dietary supplement: Placebo supplement

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Lund University
  • Uppsala, Sweden
    • CTC Clinical Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotics; Intake of a probiotic capsule once daily	Dietary supplement: Probiotic supplement; Probiotic supplement
Placebo Comparator: Placebo; Intake of a placebo capsule once daily	Dietary supplement: Placebo supplement; Placebo supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath hydrogen	The level of breath hydrogen is measured after a challenge with lactulose	4 hours

Collaborators and Investigators

• Sponsor: Probi AB

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): October 19, 2017
• Study Completion (Actual): October 19, 2017

Study Registration Dates

• First Submitted: April 26, 2017
• First Submitted That Met QC Criteria: April 26, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Flatulence
• Other Study ID Numbers: ProGastro 17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No