Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
NCT ID: NCT02397512
Last Updated: 2017-07-11
Study Results
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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COMPLETED
NA
32 participants
INTERVENTIONAL
2015-02-28
2015-10-01
Brief Summary
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Detailed Description
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Subjects will donate fecal samples 24h before and after (1-2d, 14d) lactulose ingestion. After ingestion H2-in expiratory air and symptoms will be followed for 3 hours.
Frozen samples will be analyzed for their microbiota composition and key metabolites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Lactulose group
Subjects will ingest 50g of lactulose once
application of lactulose
Subjects will ingest 50g of lactulose once
Control group
Subjects will ingest 50g of sucrose once
application of sucrose
Subjects will ingest 50g of sucrose once
Interventions
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application of lactulose
Subjects will ingest 50g of lactulose once
application of sucrose
Subjects will ingest 50g of sucrose once
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
* Working at ETH Zurich/University of Zurich, experience in handling of -80°C freezers on biosafety level 2
Exclusion Criteria
* Known diabetes mellitus, scleroderma, neurological impairment or other major current disease
* Subjects unable to stop medication that alters gut flora: proton pump inhibitors, laxatives and antibiotics at least 4 weeks before study entry.
* Pregnancy beyond week 12 (no pregnancy test will be performed)
* Involvement in any other clinical trial during the course of this trial, nor within a period of 14 days prior to its beginning or 14 days after its completion
18 Years
ALL
Yes
Sponsors
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Swiss Federal Institute of Technology in Zurich (ETHZ)
UNKNOWN
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Benjamin Misselwitz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Gerhard Rogler, MD PhD
Role: STUDY_CHAIR
University of Zurich
Locations
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Division of Gastroenterology, University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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Wotzka SY, Kreuzer M, Maier L, Zund M, Schlumberger M, Nguyen B, Fox M, Pohl D, Heinrich H, Rogler G, Biedermann L, Scharl M, Sunagawa S, Hardt WD, Misselwitz B. Microbiota stability in healthy individuals after single-dose lactulose challenge-A randomized controlled study. PLoS One. 2018 Oct 25;13(10):e0206214. doi: 10.1371/journal.pone.0206214. eCollection 2018.
Other Identifiers
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KEK-ZH-2014-0358
Identifier Type: -
Identifier Source: org_study_id
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