Intestinal Microbiome and Chemotherapy

NCT02875249 | Completed

• 1 other identifier: BRD/10/04-Q
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea

Keywords

post-antibiotic diarrhea; intestinal microbiome

Outcome Measures

Primary Outcomes (2)

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

  baseline

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

  at day 7

Interventions

patients stool collection OTHER

patients stool collection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool of patients for bacterial analysis

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuel Montassier, PH

  Nantes Univetsity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: November 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 24, 2026

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)