Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition

Not Applicable

Completed

• Conditions: Changes in Gut Microbiota Composition After Lactulose Exposure
• Interventions: Drug: application of lactulose; Other: application of sucrose

• Registration Number: NCT02397512
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Primary Completion: 2015-10-01
• Study Completion: 2015-10-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose group	application of lactulose	Subjects will ingest 50g of lactulose once
Control group	application of sucrose	Subjects will ingest 50g of sucrose once

Primary Outcome Measures

Name	Time	Method
Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)	1-2 days after ingestion of lactulose	microbiota sequencing, analysis of E. coli

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Gastroenterology, University Hospital Zurich; 🇨🇭 Zurich, Switzerland