Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2015

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.

Interventions

  • Drug: application of lactulose
    • Subjects will ingest 50g of lactulose once
  • Other: application of sucrose
    • Subjects will ingest 50g of sucrose once

Arms, Groups and Cohorts

  • Experimental: Lactulose group
    • Subjects will ingest 50g of lactulose once
  • Placebo Comparator: Control group
    • Subjects will ingest 50g of sucrose once

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis)
    • Time Frame: 1-2 days after ingestion of lactulose
    • metabolomics analysis
  • Correlation of gut microbiota composition and H2-peak (H2-measurements)
    • Time Frame: within 3 hours after lactulose ingestion
    • H2-measurements
  • Correlation of gut microbiota composition and symptoms (standardized record of symptoms)
    • Time Frame: within 3 hours after lactulose ingestion
    • standardized record of symptoms

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Collaborator
    • Swiss Federal Institute of Technology in Zurich (ETHZ)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin Misselwitz, MD, Principal Investigator, University of Zurich
    • Gerhard Rogler, MD PhD, Study Chair, University of Zurich

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