Intestinal Microbiome and Chemotherapy

NCT ID: NCT02875249

Last Updated: 2016-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diarrhea

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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patients stool collection

patients stool collection

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Montassier, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes Univetsity Hospital

Other Identifiers

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BRD/10/04-Q

Identifier Type: -

Identifier Source: org_study_id

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