Allogeneic Microbiota-reconstitution (AMR) in Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
NCT ID: NCT04095988
Last Updated: 2020-01-31
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-09-30
Study Completion Date
2021-05-31
Brief Summary
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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.
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.
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Detailed Description
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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
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
Conditions
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Diarrhea-predominant Irritable Bowel Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Verum-AMR
Patients receiving Verum-Allogeneic Microbiota Reconstitution via gastroscopy
Group Type
EXPERIMENTAL
Allogeneic microbiota reconstitution
Intervention Type
PROCEDURE
gastroscopic microbiota Infusion (Verum)
Placebo-AMR
Patients receiving Placebo(Saline)-Infusion via gastroscopy
Group Type
PLACEBO_COMPARATOR
Placebo-Allogeneic microbiota reconstitution
Intervention Type
PROCEDURE
gastroscopic saline Infusion (placebo)
Interventions
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Allogeneic microbiota reconstitution
gastroscopic microbiota Infusion (Verum)
Intervention Type
PROCEDURE
Placebo-Allogeneic microbiota reconstitution
gastroscopic saline Infusion (placebo)
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* chronic inflammatory diseases
* gastrointestinal infectious diseases
* microscopic colitis
* celiac disease
* diarrhea caused by fructose- or lactose intolerance
* gastrointestinal malignancies or intestinal polyps
* 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
* gastrointestinal infectious diseases
* microscopic colitis
* celiac disease
* diarrhea caused by fructose- or lactose intolerance
* gastrointestinal malignancies or intestinal polyps
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Klinikum Ludwigsburg
OTHER
Sponsor Role
collaborator
Helios Klinikum Krefeld
UNKNOWN
Sponsor Role
collaborator
Charite University, Berlin, Germany
OTHER
Sponsor Role
collaborator
Assign International, Berlin, Germany
UNKNOWN
Sponsor Role
collaborator
University of Ulm
OTHER
Sponsor Role
lead
Responsible Party
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Thomas Seufferlein
Director Department of Internal Medicine I
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Thomas TW Seufferlein, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ulm
Martin Wagner, Prof. Dr.
Role: STUDY_DIRECTOR
University Hospital Ulm
Thomas Frieling, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Helios Klinikum Krefeld
Locations
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Helios Klinikum Krefeld
Krefeld, , Germany
Site Status
Ulm University Hospital
Ulm, , Germany
Site Status
Countries
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Germany
References
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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.
Reference Type
BACKGROUND
Carroll 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.
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BACKGROUND
Crouzet 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.
Reference Type
BACKGROUND
El-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.
Reference Type
BACKGROUND
Frieling 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.
Reference Type
BACKGROUND
Grehan 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.
Reference Type
BACKGROUND
Hamilton 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.
Reference Type
BACKGROUND
Kajander 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.
Reference Type
BACKGROUND
Kashyap 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.
Reference Type
BACKGROUND
Keller 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.
Reference Type
BACKGROUND
Longstreth 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.
Reference Type
BACKGROUND
Lovell 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.
Reference Type
BACKGROUND
Ohman 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.
Reference Type
BACKGROUND
Parkes 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.
Reference Type
BACKGROUND
Rajilic-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.
Reference Type
BACKGROUND
Simren M, Barbara G, Flint HJ, Spiegel BM, Spiller RC, Vanner S, Verdu EF, Whorwell PJ, Zoetendal EG; Rome Foundation Committee. Intestinal microbiota in functional bowel disorders: a Rome foundation report. Gut. 2013 Jan;62(1):159-76. doi: 10.1136/gutjnl-2012-302167. Epub 2012 Jun 22.
Reference Type
BACKGROUND
Spiller R, Garsed K. Postinfectious irritable bowel syndrome. Gastroenterology. 2009 May;136(6):1979-88. doi: 10.1053/j.gastro.2009.02.074. Epub 2009 May 7.
Reference Type
BACKGROUND
van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
Reference Type
BACKGROUND
Yoon JS, Sohn W, Lee OY, Lee SP, Lee KN, Jun DW, Lee HL, Yoon BC, Choi HS, Chung WS, Seo JG. Effect of multispecies probiotics on irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial. J Gastroenterol Hepatol. 2014 Jan;29(1):52-9. doi: 10.1111/jgh.12322.
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BACKGROUND
Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875.
Reference Type
BACKGROUND
Frieling T. [Functional and inflammatory bowel disorders]. Med Klin (Munich). 2006 Mar 22;101 Suppl 1:139-42. German.
Reference Type
BACKGROUND
Kleger A, Schnell J, Essig A, Wagner M, Bommer M, Seufferlein T, Harter G. Fecal transplant in refractory Clostridium difficile colitis. Dtsch Arztebl Int. 2013 Feb;110(7):108-15. doi: 10.3238/arztebl.2013.0108. Epub 2013 Feb 15.
Reference Type
BACKGROUND
Other Identifiers
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2016-002550-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AMIRA
Identifier Type: -
Identifier Source: org_study_id
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