NCT03134469

Brief Summary

Efficacy of probiotics on excessive gas accumulation

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2017

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

April 26, 2017

Last Update Submit

September 24, 2018

Conditions

FlatulenceBloating

Outcome Measures

Primary Outcomes (1)

  • Breath hydrogen

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

    4 hours

Study Arms (2)

Probiotics

EXPERIMENTAL

Intake of a probiotic capsule once daily

Dietary Supplement: Probiotic supplement

Placebo

PLACEBO COMPARATOR

Intake of a placebo capsule once daily

Dietary Supplement: Placebo supplement

Interventions

Probiotic supplementDIETARY_SUPPLEMENT

Probiotic supplement

Probiotics
Placebo supplementDIETARY_SUPPLEMENT

Placebo supplement

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lund University

Lund, Sweden

Location

CTC Clinical Consultants

Uppsala, Sweden

Location

MeSH Terms

Conditions

Flatulence

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

April 18, 2017

Primary Completion

October 19, 2017

Study Completion

October 19, 2017

Last Updated

September 25, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)