Intestinal Microbiome and Chemotherapy

Diarrhea Clinical Trial

— EMAAD  

Official title:

Chemotherapy-driven Dysbiosis in the Intestinal Microbiome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875249
• Other study ID #: BRD/10/04-Q
• Status: Completed
• Phase: N/A
• First received: August 18, 2016
• Last updated: August 26, 2016
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: August 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diarrhea

Intervention

Other:
• patients stool collection
patients stool collection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing		baseline	No
Primary	analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing		at day 7	No