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| Name | Class |
|---|---|
| Swiss Federal Institute of Technology in Zurich (ETHZ) | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose group | Experimental | Subjects will ingest 50g of lactulose once |
|
| Control group | Placebo Comparator | Subjects will ingest 50g of sucrose once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| application of lactulose | Drug | Subjects will ingest 50g of lactulose once |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Misselwitz, MD | University of Zurich | Principal Investigator |
| Gerhard Rogler, MD PhD | University of Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Gastroenterology, University Hospital Zurich | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30359438 | Derived | 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. |
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| application of sucrose |
| Other |
Subjects will ingest 50g of sucrose once |
|
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 |