Efficacy of Probiotics on Excessive Gas Accumulation

NCT ID: NCT03134469

Last Updated: 2018-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-18

Study Completion Date

2017-10-19

Brief Summary

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Efficacy of probiotics on excessive gas accumulation

Detailed Description

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Conditions

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Flatulence Bloating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotics

Intake of a probiotic capsule once daily

Group Type EXPERIMENTAL

Probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Probiotic supplement

Placebo

Intake of a placebo capsule once daily

Group Type PLACEBO_COMPARATOR

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Interventions

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Probiotic supplement

Probiotic supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo supplement

Placebo supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Probi AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lund University

Lund, , Sweden

Site Status

CTC Clinical Consultants

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ProGastro 17

Identifier Type: -

Identifier Source: org_study_id

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