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Completed

NCT Number: NCT02397512

Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

application of lactulose

Drug

Subjects will ingest 50g of lactulose once

application of sucrose

Other

Subjects will ingest 50g of sucrose once

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss Federal Institute of Technology in Zurich (ETHZ)

Registry information

Acronym: Lactulose

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2015
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.