Bacteria Infection MechanismBBDIFFNCT07512908
Study of Factors Influencing the Dynamics of Colonisation and Decolonisation of the Digestive Tract by Clostridioides Difficile in Infants
A study testing cohort follow up in people with Bacteria Infection Mechanism, run by Fondation Hôpital Saint-Joseph.
Trial summary
Clostridioides difficile (formerly C. difficile) is a bacterium found in the form of spores (a resistant form) to which patients may be exposed in a hospital environment. Once ingested, the spore can germinate in the digestive tract in its vegetative form (active form of the bacterium) and then takes on the appearance… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bacteria Infection Mechanism
- What is being tested?
- cohort follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
For mothers
- Women aged 18 or over who are pregnant
- Patients who have been informed and have consented to participate in the research
- Patient affiliated with a health insurance plan (beneficiary or dependent), For minor patients (children)
- unborn child
- at least one parent of the child included is French-speaking
- written consent from both parents for participation in the study criteria for non-inclusion parents under guardianship or trusteeship parents deprived of their liberty parents under judicial protection children born under X/or in foster care
About this study
Official title: Study of Factors Influencing the Dynamicsof Colonisation and Decolonisation of the Digestive Tract by Clostridioides Difficile in Infants
Clostridioides difficile (formerly C. difficile) is a bacterium found in the form of spores (a resistant form) to which patients may be exposed in a hospital environment. Once ingested, the spore can germinate in the digestive tract in its vegetative form (active form of the bacterium) and then takes on the appearance of a Gram-positive bacillus that colonizes the digestive microbiota. This preliminary stage of digestive colonization by the bacterium is facilitated by certain factors, in particular exposure to antibiotics, which disrupt the composition of the digestive microbiota (dysbiosis) and thus facilitate the establishment of C. difficile following the removal of the barrier effect of the digestive microbiota. Certain strains (known as "toxinogenic") are then able to produce the main virulence factors (toxins A (TcdA) and B (TcdB)), thereby causing the main clinical signs of digestive infection, particularly in patients with risk factors for C. difficile infection (elderly people, progressive cancer, immunodepression, etc.).The treatment of CDI is mainly based on the oral administration of anti-Clostridioides difficile antibiotics such as Fidaxomicin (FDX) or Vancomycin (VAN) for a period of 10 days, according to the European recommendations of the ESCMID and the American recommendations of the IDSA. Despite effective treatment, CDI is characterized by a high recurrence rate of up to 25% of cases, with multiple recurrences that can be particularly debilitating for patients. The effect of disruption of the gut microbiota (dysbiosis) following exposure to antibiotics can be explained by several non-exclusive hypotheses, such as the disappearance of protective bacterial species in the gut microbiota or, conversely, the appearance of bacterial species that favor the colonization of C. difficile.
Hospitalization, and more generally healthcare, has often been identified as a risk factor for CDI.Indeed, C. difficile is found ubiquitously in the environment and contaminates food products. It is still difficult to assess the frequency of contamination through the ingestion of contaminated food and the potential colonization of the host.
Only the composition of the gut microbiota appears to be an interesting avenue to explore, especially since it changes significantly during the first year of life as important events occur, including dietary diversification with the introduction of the first solid foods.
- Conditions
- Bacteria Infection Mechanism
- Being tested
- cohort follow up
- Keywords
- characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cohort follow upOther
The only intervention will be in women with a vaginal swab. For children, stool samples will be collected at specific points.
| Study group | Role | What they receive |
|---|---|---|
| cohort follow-up | Other | The only intervention will be in women with a vaginal swab. For children, stool samples will be collected at specific points. Receives: Other: cohort follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants
characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants from birth to 18 months of age.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start30 May 2026 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacteria Infection MechanismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cohort study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512908
- Sponsor's protocol ID
- 772_BBDIFF
- Acronym
- BBDIFF
- Status last verified
- Aug 2025
- First submitted
- 27 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Factors Influencing the Dynamicsof Colonisation and Decolonisation of the Digestive Tract by Clostridioides Difficile in Infants
- ClinicalTrials.gov ID
- NCT07512908
- Acronym / sponsor ID
- BBDIFF / 772_BBDIFF
- Conditions
- Bacteria Infection Mechanism
- Keywords
- characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Apr 2026 (actual)
- 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.
Clostridioides difficile (formerly C. difficile) is a bacterium found in the form of spores (a resistant form) to which patients may be exposed in a hospital environment. Once ingested, the spore can germinate in the digestive tract in its vegetative form (active form of the bacterium) and then takes on the appearance of a Gram-positive bacillus that colonizes the digestive microbiota. This preliminary stage of digestive colonization by the bacterium is facilitated by certain factors, in particular exposure to antibiotics, which disrupt the composition of the digestive microbiota (dysbiosis) and thus facilitate the establishment of C. difficile following the removal of the barrier effect of the digestive microbiota. Certain strains (known as "toxinogenic") are then able to produce the main virulence factors (toxins A (TcdA) and B (TcdB)), thereby causing the main clinical signs of digestive infection, particularly in patients with risk factors for C. difficile infection (elderly people, progressive cancer, immunodepression, etc.).The treatment of CDI is mainly based on the oral administration of anti-Clostridioides difficile antibiotics such as Fidaxomicin (FDX) or Vancomycin (VAN) for a period of 10 days, according to the European recommendations of the ESCMID and the American recommendations of the IDSA. Despite effective treatment, CDI is characterized by a high recurrence rate of up to 25% of cases, with multiple recurrences that can be particularly debilitating for patients. The effect of disruption of the gut microbiota (dysbiosis) following exposure to antibiotics can be explained by several non-exclusive hypotheses, such as the disappearance of protective bacterial species in the gut microbiota or, conversely, the appearance of bacterial species that favor the colonization of C. difficile.
Hospitalization, and more generally healthcare, has often been identified as a risk factor for CDI.Indeed, C. difficile is found ubiquitously in the environment and contaminates food products. It is still difficult to assess the frequency of contamination through the ingestion of contaminated food and the potential colonization of the host.
Only the composition of the gut microbiota appears to be an interesting avenue to explore, especially since it changes significantly during the first year of life as important events occur, including dietary diversification with the introduction of the first solid foods.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cohort study
| Arm | Type | Receives |
|---|---|---|
| cohort follow-up | Other | Other: cohort follow upThe only intervention will be in women with a vaginal swab. For children, stool samples will be collected at specific points. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| cohort follow upThe only intervention will be in women with a vaginal swab. For children, stool samples will be collected at specific points. | Other | cohort follow-up |
Primary outcome
characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants
Time frame: 18 months
characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants from birth to 18 months of age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cohort follow up in people with Bacteria Infection Mechanism, run by Fondation Hôpital Saint-Joseph.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
characterize the kinetics of digestive colonization and decolonization (clearance) by C. difficile in infants (time frame: 18 months). 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 13 Apr 2026.