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

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

• Registration Number: NCT03148197
• Lead Sponsor: University of Cologne

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)

Study Timeline

• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-10
• Status Verified: 2017-07
• Study Start: 2017-07-14
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the association between changes in the intestinal microbiota and the incidence of gastrointestinal GvHD	365 days	Analyse changes over time in the intestinal microbiota using 16S ribosomal ribonucleic acid (rRNA) analysis and assess microbiota diversity.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Cologne; 🇩🇪 Cologne, Germany