MicrobiotaNCT03395548
Stability of the Microbiome in IBD and IBS
A study testing Macrogol in people with Microbiota, run by Medical University of Graz at 1 site in Austria.
Trial summary
In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Macrogol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 25 Aug 2017to 1 May 2020
- 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
- patients with inflammatory bowel disease and irritable bowel syndrome and stable therapy since three months
- patients with the indication for colonoscopy
Who cannot join
- age under 18
- pregnancy
- new therapy planned
- change of therapy within the last three months
- acute exacerbation of the inflammatory bowel disease
- colon pathologies of other origin: colocarcinoma, Illnesses with diarrhea (f.e.microscopic colitis), short bowel syndrome, malabsorption, colectomy
Show all 15Show fewer
- intake of antibiotics in the last three months
- intake of probiotics in the last month
- intake of antibiotics or probiotics during the study
- new proton pump inhibitor therapy
- significant change of nutrition in the last three months
- holidays outside europe in the last month
- gastroenteritis in the last three months
- intake of laxatives
- nonsteroidal antiinflammatory drugs should be avoided and documented
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stability of the Intestinal Microbiome in Patients Suffering From Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) Under the Influence of an Osmotic Laxans
In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.
Read the detailed description
I
- Conditions
- Microbiota
- Being tested
- Macrogol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacrogolDrug
Used drug: Macrogol (osmotic laxative)
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory bowel disease | Active comparator | The aim is to recruit 20 persons suffering from Crohn's disease or ulcerative colitis with stable medication and stable control of the disease.
As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy. Receives: Drug: Macrogol |
| Irritable bowel syndrome | Active comparator | The aim is to recruit 20 persons suffering from irritable bowel syndrome (IBS) fulfilling rome criteria.
As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy. Receives: Drug: Macrogol |
| Healthy | Active comparator | The aim is to recruit 20 persons without known illnesses with a comparable age to the other two groups.
As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy. Receives: Drug: Macrogol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the microbiome
The investigators aim to asses the changes of the gut microbiome between the three Groups and before and after lavage (Alpha Diversity, Beta Diversity, Group Significance)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start25 Aug 2017
- Primary completion1 May 2020
- Study completion1 May 2020
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 MicrobiotaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Blesl, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395548
- Sponsor's protocol ID
- 29-255 ex 16/17
- Status last verified
- Aug 2020
- First submitted
- 14 Nov 2017
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Blesl A, Binder L, Halwachs B, Baumann-Durchschein F, Furst S, Constantini-Kump P, Wenzl H, Gorkiewicz G, Hogenauer C. The Fecal Microbiome of IBD Patients Is Less Divertible by Bowel Preparation Compared to Healthy Controls: Results From a Prospective Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):2007-2018. doi: 10.1093/ibd/izaf053.
PubMed 40296371
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of the Intestinal Microbiome in Patients Suffering From Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) Under the Influence of an Osmotic Laxans
- ClinicalTrials.gov ID
- NCT03395548
- Acronym / sponsor ID
- 29-255 ex 16/17
- Conditions
- Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 10 Jan 2018 (actual)
- 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.
In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.
Detailed description
I
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inflammatory bowel disease | Active comparator | Drug: MacrogolThe aim is to recruit 20 persons suffering from Crohn's disease or ulcerative colitis with stable medication and stable control of the disease. As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy. |
| Irritable bowel syndrome | Active comparator | Drug: MacrogolThe aim is to recruit 20 persons suffering from irritable bowel syndrome (IBS) fulfilling rome criteria. As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy. |
| Healthy | Active comparator | Drug: MacrogolThe aim is to recruit 20 persons without known illnesses with a comparable age to the other two groups. As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with inflammatory bowel disease and irritable bowel syndrome and stable therapy since three months
- patients with the indication for colonoscopy
Key exclusion criteria (15 listed)
- age under 18
- pregnancy
- new therapy planned
- change of therapy within the last three months
- acute exacerbation of the inflammatory bowel disease
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 |
|---|---|---|
| MacrogolUsed drug: Macrogol (osmotic laxative) | Drug | Healthy, Inflammatory bowel disease, Irritable bowel syndrome |
Primary outcome
Changes of the microbiome
Time frame: 4 months
The investigators aim to asses the changes of the gut microbiome between the three Groups and before and after lavage (Alpha Diversity, Beta Diversity, Group Significance)
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 Aug 2020.
- Derived from this study: PubMed 40296371Blesl A, Binder L, Halwachs B, Baumann-Durchschein F, Furst S, Constantini-Kump P, Wenzl H, Gorkiewicz G, Hogenauer C. The Fecal Microbiome of IBD Patients Is Less Divertible by Bowel Preparation Compared to Healthy Controls: Results From a Prospective Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):2007-2018. doi: 10.1093/ibd/izaf053.
- Individual participant dataSharing planned: Undecided
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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.
Andreas Blesl, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macrogol in people with Microbiota, run by Medical University of Graz at 1 site in Austria.
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 2 inclusion and 15 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 Aug 2020. 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 Austria. 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. 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?
Changes of the microbiome (time frame: 4 months). 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 NCT03395548, 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 Aug 2020.