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

University of Cologne

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT03148197

COLLECT

Details and patient eligibility

About

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.

Full 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)

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Admitted for allogeneic HSCT

Description:

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

First diagnosis AML

Description:

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.