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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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.

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 groups in NCT07512908
Study groupRoleWhat they receive
cohort follow-upOtherThe 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.

  1. 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.

  1. First posted6 Apr 2026
  2. Study start30 May 2026 (estimated)
  3. Primary completion31 May 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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)
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

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.

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