DiarrheaEMAADNCT02875249
Intestinal Microbiome and Chemotherapy
An observational study of Diarrhea, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea
- What is being tested?
- patients stool collection
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diarrhea
- Being tested
- patients stool collection
- Keywords
- post-antibiotic diarrhea, intestinal microbiome
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients stool collectionOther
patients stool collection
What is being measured
The primary outcome is the main question the study is designed to answer.
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Measured: baseline
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Measured: at day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startNov 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Montassier, PH, Principal investigator, Nantes Univetsity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875249
- Sponsor's protocol ID
- BRD/10/04-Q
- Acronym
- EMAAD
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-driven Dysbiosis in the Intestinal Microbiome
- ClinicalTrials.gov ID
- NCT02875249
- Acronym / sponsor ID
- EMAAD / BRD/10/04-Q
- Conditions
- Diarrhea
- Keywords
- post-antibiotic diarrhea, intestinal microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patients stool collectionpatients stool collection | Other | – |
Primary outcome
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Time frame: baseline
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing
Time frame: at day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Montassier, PH principal investigator
Nantes Univetsity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analyze of the fecal samples using 16S ribosomal ribonucleic acid (rRNA) gene sequencing (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.