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

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 Overview

• Status: Completed
• Conditions: Changes in Gut Microbiota Composition After Lactulose Exposure
• Intervention / Treatment: Drug: application of lactulose; Other: application of sucrose

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Division of Gastroenterology, University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)	microbiota sequencing, analysis of E. coli	1-2 days after ingestion of lactulose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss Federal Institute of Technology in Zurich (ETHZ)
• Investigators: Principal Investigator: Benjamin Misselwitz, MD, University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (ESTIMATE): March 25, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: KEK-ZH-2014-0358