Diarrhea-predominant Irritable Bowel SyndromeAMIRANCT04095988
Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
A study testing Allogeneic microbiota reconstitution in people with Diarrhea-predominant Irritable Bowel Syndrome, run by University of Ulm at 2 sites in Germany.
Trial summary
The investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with diarrhea predominant-IBS (IBS-D) diagnosed according to Rome III criteria and the IBS-QOL questionnaire. Central supply and quality control of donor material will be used to control bias. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Allogeneic microbiota reconstitution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2016to May 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria
- Symptoms for > 1 year before study inclusion
- persisting symptoms > 1 year before study inclusion
- relevant symptoms with reduced Quality of Life (IBS-QOL < 60 Points)
- no specific findings in gastroscopy and colonoscopy with biopsies in the last 2 years
Who cannot join
- chronic inflammatory diseases
- gastrointestinal infectious diseases
- microscopic colitis
- celiac disease
- diarrhea caused by fructose- or lactose intolerance
- gastrointestinal malignancies or intestinal polyps
Show all 15Show fewer
- irritable bowel syndrome of other type than IBS-D
- bile acid diarrhea
- constipation
- symptoms caused by other diseases than IBS-D
- dementia
- abdominal surgery in the last months
- antibiotic therapy in the last 3 months
- pregnancy
- linguistic barrier for informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Allogeneic Microbiota-reconstitution (AMR) for the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome - the AMIRA Trial
The investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with diarrhea predominant-IBS (IBS-D) diagnosed according to Rome III criteria and the IBS-QOL questionnaire. Central supply and quality control of donor material will be used to control bias.
Primary endpoint is improvement of IBS-SSS (Severity Score System) compared to baseline. Secondary endpoints include changes in IBS-QOL, short term safety and one year follow up to control long term effects, safety and changes in and acceptance of donor microbiome after AMR using16S rDNA sequencing and quantitative diversity analysis.
Read the detailed description
This study assesses allogeneic microbiota reconstitution (AMR) as novel treatment to improve symptoms and quality of life of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
The investigators will perform a prospective multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with IBS-D diagnosed according to Rome III criteria and the IBS-QOL questionnaire.
The experimental intervention is an infusion of donor feces via gastroscopy. The placebo intervention is an infusion of sterile saline via gastroscopy.
Planned number of patients included in the study: 42 patients Planned per-protocol group: 33 patients
- Being tested
- Allogeneic microbiota reconstitution, Placebo-Allogeneic microbiota reconstitution
- Keywords
- Allogeneic microbiota reconstitution, diarrhea-predominant irritable bowel syndrome, microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic microbiota reconstitutionProcedure or surgery
gastroscopic microbiota Infusion (Verum)
Placebo-Allogeneic microbiota reconstitutionProcedure or surgery
gastroscopic saline Infusion (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Verum-AMR | Experimental | Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy Receives: Procedure: Allogeneic microbiota reconstitution |
| Placebo-AMR | Placebo comparator | Patients receiving Placebo(Saline)-Infusion via gastroscopy Receives: Procedure: Placebo-Allogeneic microbiota reconstitution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
Measured: 90 days after intervention
Secondary outcomes (3)
Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline
Measured: 90 days and 1 year after intervention
Changes and acceptance of donor microbiome (16S rDNA-analysis)
16S rDNA-analysis for microbiome biodiversity, correlation to IBS-Symptom Severity Score (IBS-SSS)
Measured: 90 days after intervention
Number of participants with treatment related adverse events
Measured: follow-up 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study startSep 2016
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Ludwigsburg, Helios Klinikum Krefeld, Charite University, Berlin, Germany, Assign International, Berlin, Germany
- Responsible party
- Principal investigator, Thomas Seufferlein, University of Ulm
- Investigators
- Thomas TW Seufferlein, Prof. Dr., Principal investigator, University Hospital UlmMartin Wagner, Prof. Dr., Study director, University Hospital UlmThomas Frieling, Prof. Dr., Principal investigator, Helios Klinikum Krefeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095988
- Sponsor's protocol ID
- AMIRA
- Other IDs
- 2016-002550-20, 2016
- Acronym
- AMIRA
- Status last verified
- Jan 2020
- First submitted
- 14 Jun 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borody TJ, George L, Andrews P, Brandl S, Noonan S, Cole P, Hyland L, Morgan A, Maysey J, Moore-Jones D. Bowel-flora alteration: a potential cure for inflammatory bowel disease and irritable bowel syndrome? Med J Aust. 1989 May 15;150(10):604. doi: 10.5694/j.1326-5377.1989.tb136704.x. No abstract available.
PubMed 2783214Carroll IM, Ringel-Kulka T, Siddle JP, Ringel Y. Alterations in composition and diversity of the intestinal microbiota in patients with diarrhea-predominant irritable bowel syndrome. Neurogastroenterol Motil. 2012 Jun;24(6):521-30, e248. doi: 10.1111/j.1365-2982.2012.01891.x. Epub 2012 Feb 20.
PubMed 22339879Crouzet L, Gaultier E, Del'Homme C, Cartier C, Delmas E, Dapoigny M, Fioramonti J, Bernalier-Donadille A. The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota. Neurogastroenterol Motil. 2013 Apr;25(4):e272-82. doi: 10.1111/nmo.12103. Epub 2013 Feb 25.
PubMed 23433203El-Serag HB, Olden K, Bjorkman D. Health-related quality of life among persons with irritable bowel syndrome: a systematic review. Aliment Pharmacol Ther. 2002 Jun;16(6):1171-85. doi: 10.1046/j.1365-2036.2002.01290.x.
PubMed 12030961Frieling T, Meis K, Kolck UW, Homann J, Hulsdonk A, Haars U, Hertfelder HJ, Oldenburg J, Seidel H, Molderings GJ. Evidence for mast cell activation in patients with therapy-resistant irritable bowel syndrome. Z Gastroenterol. 2011 Feb;49(2):191-4. doi: 10.1055/s-0029-1245707. Epub 2011 Feb 4.
PubMed 21298604Grehan MJ, Borody TJ, Leis SM, Campbell J, Mitchell H, Wettstein A. Durable alteration of the colonic microbiota by the administration of donor fecal flora. J Clin Gastroenterol. 2010 Sep;44(8):551-61. doi: 10.1097/MCG.0b013e3181e5d06b.
PubMed 20716985Hamilton MJ, Weingarden AR, Unno T, Khoruts A, Sadowsky MJ. High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. Gut Microbes. 2013 Mar-Apr;4(2):125-35. doi: 10.4161/gmic.23571. Epub 2013 Jan 18.
PubMed 23333862Kajander K, Myllyluoma E, Rajilic-Stojanovic M, Kyronpalo S, Rasmussen M, Jarvenpaa S, Zoetendal EG, de Vos WM, Vapaatalo H, Korpela R. Clinical trial: multispecies probiotic supplementation alleviates the symptoms of irritable bowel syndrome and stabilizes intestinal microbiota. Aliment Pharmacol Ther. 2008 Jan 1;27(1):48-57. doi: 10.1111/j.1365-2036.2007.03542.x. Epub 2007 Oct 5.
PubMed 17919270Kashyap PC, Marcobal A, Ursell LK, Larauche M, Duboc H, Earle KA, Sonnenburg ED, Ferreyra JA, Higginbottom SK, Million M, Tache Y, Pasricha PJ, Knight R, Farrugia G, Sonnenburg JL. Complex interactions among diet, gastrointestinal transit, and gut microbiota in humanized mice. Gastroenterology. 2013 May;144(5):967-77. doi: 10.1053/j.gastro.2013.01.047. Epub 2013 Feb 1.
PubMed 23380084Keller J, Wedel T, Seidl H, Kreis ME, Andresen V, Preiss JC, Layer P, van der Voort I. [S3 guideline of the German Society for Digestive and Metabolic Diseases (DGVS) and the German Society for Neurogastroenterology and Motility (DGNM) to the definition, pathophysiology, diagnosis and treatment of intestinal motility]. Z Gastroenterol. 2011 Mar;49(3):374-90. doi: 10.1055/s-0029-1245993. Epub 2011 Mar 9. No abstract available. German.
PubMed 21391171Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
PubMed 16678561Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
PubMed 22426087Ohman L, Simren M. Pathogenesis of IBS: role of inflammation, immunity and neuroimmune interactions. Nat Rev Gastroenterol Hepatol. 2010 Mar;7(3):163-73. doi: 10.1038/nrgastro.2010.4. Epub 2010 Jan 26.
PubMed 20101257Parkes GC, Rayment NB, Hudspith BN, Petrovska L, Lomer MC, Brostoff J, Whelan K, Sanderson JD. Distinct microbial populations exist in the mucosa-associated microbiota of sub-groups of irritable bowel syndrome. Neurogastroenterol Motil. 2012 Jan;24(1):31-9. doi: 10.1111/j.1365-2982.2011.01803.x. Epub 2011 Nov 9.
PubMed 22070725Rajilic-Stojanovic M, Heilig HG, Tims S, Zoetendal EG, de Vos WM. Long-term monitoring of the human intestinal microbiota composition. Environ Microbiol. 2012 Oct 15. doi: 10.1111/1462-2920.12023. Online ahead of print.
PubMed 23286720
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Microbiota-reconstitution (AMR) for the Treatment of Patients With Diarrhea-predominant Irritable Bowel Syndrome - the AMIRA Trial
- ClinicalTrials.gov ID
- NCT04095988
- Acronym / sponsor ID
- AMIRA / AMIRA
- Keywords
- Allogeneic microbiota reconstitution, diarrhea-predominant irritable bowel syndrome, microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- Klinikum Ludwigsburg, Helios Klinikum Krefeld, Charite University, Berlin, Germany, Assign International, Berlin, Germany
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 19 Sep 2019 (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.
The investigators will perform a multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with diarrhea predominant-IBS (IBS-D) diagnosed according to Rome III criteria and the IBS-QOL questionnaire. Central supply and quality control of donor material will be used to control bias.
Primary endpoint is improvement of IBS-SSS (Severity Score System) compared to baseline. Secondary endpoints include changes in IBS-QOL, short term safety and one year follow up to control long term effects, safety and changes in and acceptance of donor microbiome after AMR using16S rDNA sequencing and quantitative diversity analysis.
Detailed description
This study assesses allogeneic microbiota reconstitution (AMR) as novel treatment to improve symptoms and quality of life of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
The investigators will perform a prospective multicenter, 2:1 randomized, double-blinded, placebo-controlled trial of AMR in patients with IBS-D diagnosed according to Rome III criteria and the IBS-QOL questionnaire.
The experimental intervention is an infusion of donor feces via gastroscopy. The placebo intervention is an infusion of sterile saline via gastroscopy.
Planned number of patients included in the study: 42 patients Planned per-protocol group: 33 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum-AMR | Experimental | Procedure: Allogeneic microbiota reconstitutionPatients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy |
| Placebo-AMR | Placebo comparator | Procedure: Placebo-Allogeneic microbiota reconstitutionPatients receiving Placebo(Saline)-Infusion via gastroscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent
- irritable bowel syndrome of diarrhea-predominant type according to ROME III criteria
- Symptoms for > 1 year before study inclusion
- persisting symptoms > 1 year before study inclusion
- relevant symptoms with reduced Quality of Life (IBS-QOL < 60 Points)
Key exclusion criteria (15 listed)
- chronic inflammatory diseases
- gastrointestinal infectious diseases
- microscopic colitis
- celiac disease
- diarrhea caused by fructose- or lactose intolerance
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 |
|---|---|---|
| Allogeneic microbiota reconstitutiongastroscopic microbiota Infusion (Verum) | Procedure or surgery | Verum-AMR |
| Placebo-Allogeneic microbiota reconstitutiongastroscopic saline Infusion (placebo) | Procedure or surgery | Placebo-AMR |
Primary outcome
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline
Time frame: 90 days after intervention
3 secondary outcomes
Improvement of IBS-QOL using IBS-QOL-questionnaire compared to baseline
Time frame: 90 days and 1 year after intervention
Changes and acceptance of donor microbiome (16S rDNA-analysis)
Time frame: 90 days after intervention
Number of participants with treatment related adverse events
Time frame: follow-up 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Background: PubMed 2783214Borody TJ, George L, Andrews P, Brandl S, Noonan S, Cole P, Hyland L, Morgan A, Maysey J, Moore-Jones D. Bowel-flora alteration: a potential cure for inflammatory bowel disease and irritable bowel syndrome? Med J Aust. 1989 May 15;150(10):604. doi: 10.5694/j.1326-5377.1989.tb136704.x. No abstract available.
- Background: PubMed 22339879Carroll IM, Ringel-Kulka T, Siddle JP, Ringel Y. Alterations in composition and diversity of the intestinal microbiota in patients with diarrhea-predominant irritable bowel syndrome. Neurogastroenterol Motil. 2012 Jun;24(6):521-30, e248. doi: 10.1111/j.1365-2982.2012.01891.x. Epub 2012 Feb 20.
- Background: PubMed 23433203Crouzet L, Gaultier E, Del'Homme C, Cartier C, Delmas E, Dapoigny M, Fioramonti J, Bernalier-Donadille A. The hypersensitivity to colonic distension of IBS patients can be transferred to rats through their fecal microbiota. Neurogastroenterol Motil. 2013 Apr;25(4):e272-82. doi: 10.1111/nmo.12103. Epub 2013 Feb 25.
- Background: PubMed 12030961El-Serag HB, Olden K, Bjorkman D. Health-related quality of life among persons with irritable bowel syndrome: a systematic review. Aliment Pharmacol Ther. 2002 Jun;16(6):1171-85. doi: 10.1046/j.1365-2036.2002.01290.x.
- Background: PubMed 21298604Frieling T, Meis K, Kolck UW, Homann J, Hulsdonk A, Haars U, Hertfelder HJ, Oldenburg J, Seidel H, Molderings GJ. Evidence for mast cell activation in patients with therapy-resistant irritable bowel syndrome. Z Gastroenterol. 2011 Feb;49(2):191-4. doi: 10.1055/s-0029-1245707. Epub 2011 Feb 4.
- Background: PubMed 20716985Grehan MJ, Borody TJ, Leis SM, Campbell J, Mitchell H, Wettstein A. Durable alteration of the colonic microbiota by the administration of donor fecal flora. J Clin Gastroenterol. 2010 Sep;44(8):551-61. doi: 10.1097/MCG.0b013e3181e5d06b.
- Background: PubMed 23333862Hamilton MJ, Weingarden AR, Unno T, Khoruts A, Sadowsky MJ. High-throughput DNA sequence analysis reveals stable engraftment of gut microbiota following transplantation of previously frozen fecal bacteria. Gut Microbes. 2013 Mar-Apr;4(2):125-35. doi: 10.4161/gmic.23571. Epub 2013 Jan 18.
- Background: PubMed 17919270Kajander K, Myllyluoma E, Rajilic-Stojanovic M, Kyronpalo S, Rasmussen M, Jarvenpaa S, Zoetendal EG, de Vos WM, Vapaatalo H, Korpela R. Clinical trial: multispecies probiotic supplementation alleviates the symptoms of irritable bowel syndrome and stabilizes intestinal microbiota. Aliment Pharmacol Ther. 2008 Jan 1;27(1):48-57. doi: 10.1111/j.1365-2036.2007.03542.x. Epub 2007 Oct 5.
- Background: PubMed 23380084Kashyap PC, Marcobal A, Ursell LK, Larauche M, Duboc H, Earle KA, Sonnenburg ED, Ferreyra JA, Higginbottom SK, Million M, Tache Y, Pasricha PJ, Knight R, Farrugia G, Sonnenburg JL. Complex interactions among diet, gastrointestinal transit, and gut microbiota in humanized mice. Gastroenterology. 2013 May;144(5):967-77. doi: 10.1053/j.gastro.2013.01.047. Epub 2013 Feb 1.
- Background: PubMed 21391171Keller J, Wedel T, Seidl H, Kreis ME, Andresen V, Preiss JC, Layer P, van der Voort I. [S3 guideline of the German Society for Digestive and Metabolic Diseases (DGVS) and the German Society for Neurogastroenterology and Motility (DGNM) to the definition, pathophysiology, diagnosis and treatment of intestinal motility]. Z Gastroenterol. 2011 Mar;49(3):374-90. doi: 10.1055/s-0029-1245993. Epub 2011 Mar 9. No abstract available. German.
- Background: PubMed 16678561Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
- Background: PubMed 22426087Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
- Individual participant dataSharing planned: No
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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.
Thomas TW Seufferlein, Prof. Dr. principal investigator
University Hospital Ulm
Martin Wagner, Prof. Dr. study director
University Hospital Ulm
Thomas Frieling, Prof. Dr. principal investigator
Helios Klinikum Krefeld
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic microbiota reconstitution in people with Diarrhea-predominant Irritable Bowel Syndrome, run by University of Ulm at 2 sites in Germany.
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 6 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
Results are not available in the source record.
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?
Decrease of the IBS-SSS questionnaire > 105 Points compared to baseline (time frame: 90 days after intervention). 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 NCT04095988, which also lists 22 linked publications.
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 31 Jan 2020.