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

NCT ID: NCT03148197

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-14
• Study Completion Date: 2019-12-31

Brief 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.

Detailed 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)

Conditions

Acute Myeloid Leukemia; Graft-versus-host-disease; Allogeneic Hematopoietic Stem Cell Transplantation; Stem Cell Transplant Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Admitted for allogeneic HSCT

Patients admitted for performance of an allogeneic HSCT after high dosis chemotherapy.

No interventions assigned to this group

First diagnosis AML

Patients admitted with a first diagnosis of an acute myeloid leukemia for chemotherapy. Depending on factors like age or molecular risk profile some of these patients will proceed to allogeneic HSCT.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Maria J.G.T. Vehreschild

PD MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Vehreschild, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne, Department of Internal Medicine / Infectious Diseases, Cologne, Germany

Locations

University Hospital of Cologne

Cologne, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Maria Vehreschild, MD

Role: CONTACT

maria.vehreschild@uk-koeln.de

+49 221 478 88794

Facility Contacts

Maria Vehreschild, MD

Role: primary

maria.vehreschild@uk-koeln.de

+49 221 478 88794

References

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.

Reference Type: BACKGROUND

PMID: 24939656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25977230 (View on PubMed)

Weber D, Oefner PJ, Hiergeist A, Koestler J, Gessner A, Weber M, Hahn J, Wolff D, Stammler 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.

Reference Type: BACKGROUND

PMID: 26209659 (View on PubMed)

Other Identifiers

COLLECT

Identifier Type: -

Identifier Source: org_study_id