Clinical trial NCT02397512: Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
Official title: Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Changes in Gut Microbiota Composition After Lactulose Exposure
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology in Zurich (ETHZ)
First posted: 2015-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)
timeFrame: 1-2 days after ingestion of lactulose
Secondary outcomes:
measure: Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis)
timeFrame: 1-2 days after ingestion of lactulose
measure: Correlation of gut microbiota composition and H2-peak (H2-measurements)
timeFrame: within 3 hours after lactulose ingestion
measure: Correlation of gut microbiota composition and symptoms (standardized record of symptoms)
timeFrame: within 3 hours after lactulose ingestion
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Gastroenterology, University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Benjamin Misselwitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zurich
name: Gerhard Rogler, MD PhD
role: STUDY_CHAIR
References:
citation: 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.