DiarrheaNCT02534272
Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota
An observational study of Diarrhea, run by University Hospital, Strasbourg, France at 4 sites in France.
Trial summary
D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Stool sampling and sequencing of gut microbiota.
- How many people
- 27 participants
- Where
- 4 sitesFrance
- Study dates
- 16 Feb 2016to 29 Mar 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Symptomatic subjects will be recruited during their visit to hospital for intestinal symptoms. Asymptomatic subjects will be recruited in the general population.
Who may be able to join
- male/female aged at least of 18 years
- subject with abdominal pain, diarrhea, bloating
- no other known intestinal disease
- male/female aged at least of 18 years
- no known intestinal disease
Who cannot join
- chronic intestinal diseases such as IBD, IBS …
- intake of antibiotic or probiotic within the 2 last months
- subject in exclusion period
- subject unable to understand information for a free consent to the study
- subject in safeguarding justice or guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Laboratoire de Parasitologie et de Mycologie Médicale du Plateau Technique de Microbiologie des Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Médecine interne, maladies tropicales et infectieuses Hôpital Civil
Strasbourg, 67091
Service de Médecine Interne - Diabète et Maladies métaboliques Hôpital Civil
Strasbourg, 67091
Service d'hépato gastro-entérologie et assistance nutritive Hôpital Hautepierre
Strasbourg, 67098
About this study
D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.
- Conditions
- Diarrhea
- Being tested
- Stool sampling and sequencing of gut microbiota.
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampling and sequencing of gut microbiota.Other
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic subjects | Subjects with intestinal symptoms Receives: Other: Stool sampling and sequencing of gut microbiota. | |
| Asymptomatic subjects | Subjects without intestinal symptoms Receives: Other: Stool sampling and sequencing of gut microbiota. |
What is being measured
The primary outcome is the main question the study is designed to answer.
16SrRNA copy numbers
Measured: Within the 2 days following inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start16 Feb 2016
- Primary completion29 Mar 2019
- Study completion29 Mar 2019
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 University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CANDOLFI Ermanno, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534272
- Sponsor's protocol ID
- 6110
- Status last verified
- Mar 2025
- First submitted
- 24 Aug 2015
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interactions Between Dientamoba Fragilis and the Gut Microbiota
- ClinicalTrials.gov ID
- NCT02534272
- Acronym / sponsor ID
- 6110
- Conditions
- Diarrhea
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 29 Mar 2019 (actual)
- First posted
- 27 Aug 2015 (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.
D.fragilis is an intestinal protozoon that feeds by phagocytosis of intestinal bacteria. The study aim to determine if the carriage of the intestinal parasite D.fragilis is associated to changes of gut microbiota in subjects presenting with or without intestinal symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic subjects | – | Other: Stool sampling and sequencing of gut microbiota.Subjects with intestinal symptoms |
| Asymptomatic subjects | – | Other: Stool sampling and sequencing of gut microbiota.Subjects without intestinal symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic subjects will be recruited during their visit to hospital for intestinal symptoms. Asymptomatic subjects will be recruited in the general population.
Key inclusion criteria (5 listed)
- male/female aged at least of 18 years
- subject with abdominal pain, diarrhea, bloating
- no other known intestinal disease
- male/female aged at least of 18 years
- no known intestinal disease
Key exclusion criteria (5 listed)
- chronic intestinal diseases such as IBD, IBS …
- intake of antibiotic or probiotic within the 2 last months
- subject in exclusion period
- subject unable to understand information for a free consent to the study
- subject in safeguarding justice or guardianship
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 |
|---|---|---|
| Stool sampling and sequencing of gut microbiota. | Other | Asymptomatic subjects, Symptomatic subjects |
Primary outcome
16SrRNA copy numbers
Time frame: Within the 2 days following inclusion
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
CANDOLFI Ermanno, MD principal investigator
Hôpitaux Universitaires de Strasbourg
4 sites 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 University Hospital, Strasbourg, France at 4 sites 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early. Results are not available in the source record.
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?
16SrRNA copy numbers (time frame: Within the 2 days following inclusion). 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 12 Mar 2025.