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OpenTrials
Completed

NCT Number: NCT02875249

Intestinal Microbiome and Chemotherapy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

patients stool collection

Other

patients stool collection

Primary outcomes

  1. analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing

    Time frame: baseline

  2. analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing

    Time frame: at day 7

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Chemotherapy-driven Dysbiosis in the Intestinal Microbiome

Acronym: EMAAD

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 23, 2016
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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