NCT02397512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

March 18, 2015

Last Update Submit

July 10, 2017

Conditions

Changes in Gut Microbiota Composition After Lactulose Exposure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis)

    1-2 days after ingestion of lactulose

  • Correlation of gut microbiota composition and H2-peak (H2-measurements)

    within 3 hours after lactulose ingestion

  • Correlation of gut microbiota composition and symptoms (standardized record of symptoms)

    within 3 hours after lactulose ingestion

Study Arms (2)

Lactulose group

EXPERIMENTAL

Subjects will ingest 50g of lactulose once

Drug: application of lactulose

Control group

PLACEBO COMPARATOR

Subjects will ingest 50g of sucrose once

Other: application of sucrose

Interventions

application of lactuloseDRUG

Subjects will ingest 50g of lactulose once

Lactulose group
application of sucroseOTHER

Subjects will ingest 50g of sucrose once

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30359438DERIVED

Study Officials

  • Benjamin Misselwitz, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

  • Gerhard Rogler, MD PhD

    University of Zurich

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 25, 2015

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

CH(1)