Changes in Gut Microbiota Composition After Lactulose ExposureLactuloseNCT02397512
Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
A study testing application of lactulose and application of sucrose in people with Changes in Gut Microbiota Composition After Lactulose Exposure, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Changes in Gut Microbiota Composition After Lactulose Exposure
- What is being tested?
- application of lactulose and application of sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2015to 1 Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of Gastroenterology, University Hospital Zurich
Zurich, 8091
About this study
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.
Read the 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.
- Being tested
- application of lactulose, application of sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of lactuloseDrug
Subjects will ingest 50g of lactulose once
application of sucroseOther
Subjects will ingest 50g of sucrose once
| Study group | Role | What they receive |
|---|---|---|
| Lactulose group | Experimental | Subjects will ingest 50g of lactulose once Receives: Drug: application of lactulose |
| Control group | Placebo comparator | Subjects will ingest 50g of sucrose once Receives: Other: application of sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)
microbiota sequencing, analysis of E. coli
Measured: 1-2 days after ingestion of lactulose
Secondary outcomes (3)
Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis)
metabolomics analysis
Measured: 1-2 days after ingestion of lactulose
Correlation of gut microbiota composition and H2-peak (H2-measurements)
H2-measurements
Measured: within 3 hours after lactulose ingestion
Correlation of gut microbiota composition and symptoms (standardized record of symptoms)
standardized record of symptoms
Measured: within 3 hours after lactulose ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion1 Oct 2015
- Study completion1 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Changes in Gut Microbiota Composition After Lactulose ExposureStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology in Zurich (ETHZ)
- Responsible party
- Sponsor
- Investigators
- Benjamin Misselwitz, MD, Principal investigator, University of ZurichGerhard Rogler, MD PhD, Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397512
- Sponsor's protocol ID
- KEK-ZH-2014-0358
- Acronym
- Lactulose
- Status last verified
- Jul 2017
- First submitted
- 18 Mar 2015
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30359438
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Influence of Lactulose Intake on the Gut Microbiota Composition
- ClinicalTrials.gov ID
- NCT02397512
- Acronym / sponsor ID
- Lactulose / KEK-ZH-2014-0358
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology in Zurich (ETHZ)
- Study start
- Feb 2015
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Oct 2015 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose group | Experimental | Drug: application of lactuloseSubjects will ingest 50g of lactulose once |
| Control group | Placebo comparator | Other: application of sucroseSubjects will ingest 50g of sucrose once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of lactuloseSubjects will ingest 50g of lactulose once | Drug | Lactulose group |
| application of sucroseSubjects will ingest 50g of sucrose once | Other | Control group |
Primary outcome
Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli)
Time frame: 1-2 days after ingestion of lactulose
microbiota sequencing, analysis of E. coli
3 secondary outcomes
Influence of lactulose intake on metabolic profiles within the fecal ecoystem (metabolomics analysis)
Time frame: 1-2 days after ingestion of lactulose
Correlation of gut microbiota composition and H2-peak (H2-measurements)
Time frame: within 3 hours after lactulose ingestion
Correlation of gut microbiota composition and symptoms (standardized record of symptoms)
Time frame: within 3 hours after lactulose ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 30359438Wotzka 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Misselwitz, MD principal investigator
University of Zurich
Gerhard Rogler, MD PhD study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of lactulose and application of sucrose in people with Changes in Gut Microbiota Composition After Lactulose Exposure, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of lactulose intake on gut microbiota composition (microbiota sequencing, analysis of E. coli) (time frame: 1-2 days after ingestion of lactulose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.