Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

Changes in Gut Microbiota Composition After Lactulose Exposure Clinical Trial

— Lactulose  

Official title:

Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02397512
• Other study ID #: KEK-ZH-2014-0358
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: July 10, 2017
• Start date: February 2015
• Est. completion date: October 1, 2015

Study information

• Verified date: July 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 1, 2015
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Changes in Gut Microbiota Composition After Lactulose Exposure

Intervention

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

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

Locations

Country	Name	City	State
Switzerland	Division of Gastroenterology, University Hospital Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology in Zurich (ETHZ)

Country where clinical trial is conducted

Switzerland, 

Outcome

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