Changes in the Gut Microbiota of Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)

Acute Myeloid Leukemia Clinical Trial

— COLLECT  

Official title:

Changes Over Time in the Gut Microbiota of High-risk Hematological Patients Undergoing Allogeneic Stem Cell Transplantation (COLLECT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03148197
• Other study ID #: COLLECT
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2017
• Last updated: July 17, 2017
• Start date: July 14, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2017
• Source: University of Cologne
• Contact: Maria Vehreschild, MD
• Phone: +49 221 478 88794
• Email: maria.vehreschild[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COLLECT is a monocentric, prospective, observational study, which aims to assess the association between changes in the intestinal microbiota and the incidence of gastrointestinal graft-versus-host diseases (GvHD). Patients admitted for performance of an allogeneic hematopoietic stem cell transplantation (HSCT) or patients with a first diagnosis of an acute myeloid leukemia (AML) will be enrolled and stool samples will be analyzed using next-generation sequencing. In addition to stool, blood and urine samples will be collected for cytokine and 3-indoxylsulfate analysis.

Exposure to drugs will not be influenced and remains at the discretion of the treating physician.

Description:

Documentation of patient is performed by using the web-based survey platform www.ClinicalSurveys.net which was set up by researchers of the University Hospital of Cologne. This survey platform enables an optimal performance in epidemiological, observational, and interventional trials and is characterized by layered access security and frequent data backup. It has been used for numerous registry and cohort studies with approval of competent authorities and ethics boards.

The following data items of patients with a written informed consent are prospectively documented into our database:

• Demographics

• Chemotherapeutic agents

• Other immunosuppressives

• Radiation treatment

• Antibiotic prophylaxis and treatment

• Bowel movement abnormalities

• HSCT Donor and recipient information

• Status of hematological disease

• Days with neutropenia

• Fever and infectious complications

The following samples of patients with a written informed consent are prospectively collected, stored and analyzed:

• Stool samples (16S rRNA analysis)

• Urine (3-IS analysis)

• Ethylenediaminetetraacetic acid (EDTA) blood samples (PBMCs Fluorescence-activated cell sorting (FACS) analysis)

• Citrate blood samples (cytokine analysis)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of at least 18 years

• Patients admitted for performance of an allogeneic HSCT OR

• Patients with a first diagnosis of an acute myeloid leukemia

• No contraindication for an allogeneic stem cell transplantation

• Subject is not legally incapacitated

• Written informed consent from the study subject has been obtained

Exclusion Criteria:

• Active inflammatory bowel disease

• Ongoing gastroenteritis at the time of inclusion

• Patient has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the patient participating in the study, would make it unlikely for the patient to complete the study, or would confound the results of the study

• Persons with any kind of dependency on the investigator or employed by the sponsor or investigator

• Persons held in an institution by legal or official order

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Allogeneic Hematopoietic Stem Cell Transplantation
• Graft vs Host Disease
• Graft-versus-host-disease
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Stem Cell Transplant Complications

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Jenq RR, Taur Y, Devlin SM, Ponce DM, Goldberg JD, Ahr KF, Littmann ER, Ling L, Gobourne AC, Miller LC, Docampo MD, Peled JU, Arpaia N, Cross JR, Peets TK, Lumish MA, Shono Y, Dudakov JA, Poeck H, Hanash AM, Barker JN, Perales MA, Giralt SA, Pamer EG, van den Brink MR. Intestinal Blautia Is Associated with Reduced Death from Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2015 Aug;21(8):1373-83. doi: 10.1016/j.bbmt.2015.04.016. Epub 2015 May 11. — View Citation

Taur Y, Jenq RR, Perales MA, Littmann ER, Morjaria S, Ling L, No D, Gobourne A, Viale A, Dahi PB, Ponce DM, Barker JN, Giralt S, van den Brink M, Pamer EG. The effects of intestinal tract bacterial diversity on mortality following allogeneic hematopoietic stem cell transplantation. Blood. 2014 Aug 14;124(7):1174-82. doi: 10.1182/blood-2014-02-554725. Epub 2014 Jun 17. — View Citation

Weber D, Oefner PJ, Hiergeist A, Koestler J, Gessner A, Weber M, Hahn J, Wolff D, Stämmler F, Spang R, Herr W, Dettmer K, Holler E. Low urinary indoxyl sulfate levels early after transplantation reflect a disrupted microbiome and are associated with poor outcome. Blood. 2015 Oct 1;126(14):1723-8. doi: 10.1182/blood-2015-04-638858. Epub 2015 Jul 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD	Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.	365 days
Secondary	Assessment of the association between changes in the intestinal microbiota and the incidence of non-relapse mortality	Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.	365 days
Secondary	Investigation of the influence of antibiotics and other risk factors on microbiota changes within this cohort	Analyse changes over time in the intestinal microbiota using 16S rRNA analysis and assess microbiota diversity.	365 days
Secondary	Analysis of the association of 3-indoxylsulfate 3-IS in urine/blood with observed microbiota changes	3-indoxylsulfate (3-IS) concentration levels will be quantified using liquid chromatography in combination with mass spectrometry.	365 days
Secondary	Assessment of the effect of microbiota dysbiosis on cytokine and lymphocyte profiles	Cytokine analysis will be performed on the collected plasma samples (citrate) using multiplex assays and read on a Luminex100™ platform.	365 days