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OpenTrials
Completed

NCT Number: NCT03134469

Efficacy of Probiotics on Excessive Gas Accumulation

Efficacy of probiotics on excessive gas accumulation

Completed

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Key information

Conditions

Flatulence Bloating Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University, Lund, Sweden

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic supplement

Dietary Supplement

Probiotic supplement

Placebo supplement

Dietary Supplement

Placebo supplement

Primary outcomes

  1. Breath hydrogen

    Time frame: 4 hours

    The level of breath hydrogen is measured after a challenge with lactulose

Sponsors and collaborators

Lead sponsor

Probi AB

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 1, 2017
Registry last updated
Sep 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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