Intestinal Microbiome and Chemotherapy (EMAAD)

August 26, 2016 updated by: Nantes University Hospital

Chemotherapy-driven Dysbiosis in the Intestinal Microbiome

Chemotherapy is commonly used as myeloablative conditioning treatment to prepare patients for haematopoietic stem cell transplantation (HSCT). Chemotherapy leads to several side effects, with gastrointestinal (GI) mucositis being one of the most frequent. Current models of GI mucositis pathophysiology are generally silent on the role of the intestinal microbiome.

The aim of the study is to identify functional mechanisms by which the intestinal microbiome may play a key role in the pathophysiology of GI mucositis, the investigators applied high throughput DNA-sequencing analysis to identify microbes and microbial functions that are modulated following chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients, men and women, 18 to 65, who receive intravenous antibiotics broad spectrum (Tazocilline (piperacillin tazobactam) and Amiklin (amikacin)) in support of the context of febrile neutropenia following a autologous stem cells.

Description

Inclusion Criteria:

  • Participants with non-Hodgkin's lymphoma
  • Participants receiving the same myeloablative conditioning regimen for five consecutive days, including high-dose Carmustine (Bis-chloroethylnitrosourea), Etoposide, Aracytine and Melphalan.

Exclusion Criteria:

  • Patients with a history of Inflammatory Bowel Diseases (IBD), exposed to probiotics, prebiotics or broad-spectrum antibiotics, or administered nasal-tube feeding or parenteral nutrition in the month prior to initiation of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Time Frame: baseline
baseline
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Time Frame: at day 7
at day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Emmanuel Montassier, PH, Nantes Univetsity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/04-Q

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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