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Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition (Lactulose)

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ClinicalTrials.gov Identifier: NCT02397512
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Swiss Federal Institute of Technology in Zurich (ETHZ)
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
This study will test the influence of lactulose of the human gut microbiota. Healthy volunteers will ingest 50g of lactulose and donate stool samples 1 day before as well as 1-2 days and 14 days after the test. Using sequencing and metabolomics techniques the investigators will identify changes in microbiota composition upon lactulose exposure.

Condition or disease Intervention/treatment Phase
Changes in Gut Microbiota Composition After Lactulose Exposure Drug: application of lactulose Other: application of sucrose Not Applicable

Detailed Description:

This is a clinical study for investigating the influence of lactulose on the composition and metabolic activities of the intestinal microbiota. We will recruit 40 healthy volunteers. Subjects will be randomized and receive either 50g lactose (intervention group) or 50g sucrose (control group).

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
Study Start Date : February 2015
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lactulose group
Subjects will ingest 50g of lactulose once
Drug: application of lactulose
Subjects will ingest 50g of lactulose once

Placebo Comparator: Control group
Subjects will ingest 50g of sucrose once
Other: application of sucrose
Subjects will ingest 50g of sucrose once




Primary Outcome Measures :
  1. Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli) [ Time Frame: 1-2 days after ingestion of lactulose ]
    microbiota sequencing, analysis of E. coli


Secondary Outcome Measures :
  1. Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis) [ Time Frame: 1-2 days after ingestion of lactulose ]
    metabolomics analysis

  2. Correlation of gut microbiota composition and H2-peak (H2-measurements) [ Time Frame: within 3 hours after lactulose ingestion ]
    H2-measurements

  3. Correlation of gut microbiota composition and symptoms (standardized record of symptoms) [ Time Frame: within 3 hours after lactulose ingestion ]
    standardized record of symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects free of relevant abdominal complaints (=healthy)
  • Written informed consent
  • Working at ETH Zurich/University of Zurich, experience in handling of -80°C freezers on biosafety level 2

Exclusion Criteria:

  • Previous history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397512


Locations
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Switzerland
Division of Gastroenterology, University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Swiss Federal Institute of Technology in Zurich (ETHZ)
Investigators
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Principal Investigator: Benjamin Misselwitz, MD University of Zurich
Study Chair: Gerhard Rogler, MD PhD University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02397512     History of Changes
Other Study ID Numbers: KEK-ZH-2014-0358
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Lactulose
Gastrointestinal Agents