Clostridioides Difficile InfectionPhase 1CloDiCoNCT05693077
Clostridioides Difficile Colonisation
A Phase 1 study testing 10E4 NTCD spores, 10E7 NTCD spores and Vancomycin Oral Capsule in people with Clostridioides Difficile Infection, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD to ultimately determine host microbiota factors associated with susceptibility to colonisation. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- 10E4 NTCD spores, 10E7 NTCD spores and Vancomycin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Sep 2023to Jun 2025
- Phase
- Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject is aged ≥ 18 and ≤ 45 years and in good health.
- Subject has adequate understanding of the procedures of the study and is able and willing to abide strictly thereby.
- For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- Subject has signed informed consent.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any physical or psychiatric illness or conditions that could threaten or compromise the health of the subject during the study, influence their ability to participate in the trial or interfere with the interpretation of the study results, as determined by the trial physician.
- Use of antibiotics (or other microbiota influencing products) within one month prior to inclusion.
- Known immunosuppressive condition, including infection with Human Immunodeficiency Virus (HIV), use of systemic corticosteroids or other immune modifying drugs (with exception of antihistamines and topical steroids).
- Regular use (defined by more than once weekly) of proton-pump inhibitors or H2- blockers during one month prior to inclusion.
- The use of strong P-glycoprotein-inhibitors (like Ciclosporin, Ketoconazole, Erythromycin, Clarithromycin, Verapamil and Amiodaron).
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- Known allergy to vancomycin, metronidazole or fidaxomicin.
- Known allergy to glycerol.
- Known immunodeficiency disorders.
- Known gastro-intestinal disease including but not limited to inflammatory bowel diseases (Crohn's disease, Colitis Ulcerosa), recent gastro-intestinal surgery, constipation defined by bowel movements less than every second day.
- Positive fecal PCR with Clostridiodes or SSYC (Salmonella, Shigella, Yersinia or Campylobacter spp.) at screening.
- Any condition that would put household members at a greater risk for transmission e.g. no access or use of flush toilet, household members belonging to vulnerable populations such as persons who are immunocompromised, children younger than 2 years of age and elderly older than 70 years of age.
- For women of child bearing potential: a positive urine pregnancy test before inclusion or lactating at screening / during the trial.
- Being an employee or student of the Experimental bacteriology group or the controlled human infection center at LUMC.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333 ZA
M. Roestenberg, MD. PhD.
M. Roestenberg, MD. PhD.
About this study
Official title: Establishing Colonisation With Non-toxigenic Clostridioides Difficile in Healthy Volunteers
This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD to ultimately determine host microbiota factors associated with susceptibility to colonisation.
Read the detailed description
This will be an adaptive dose design, randomized double-blind controlled clinical trial investigating oral exposure to NTCD spores in healthy volunteers. The trial will consist of two or, if necessary, three different consecutive intervention phases. The second and third phase are dependent on results of the preliminary phases. In every phase one cohort volunteers will be randomized to different dose levels of NTCD spores or placebo.
50 to 70 healthy volunteers will be included, of which in total 10 volunteers will be exposed to placebo.
The first phase will consist of 24 volunteers, randomized in three groups: group A (N=10) will receive 5 doses of 10E4 NTCD spores, group B (N=10) will receive 5 doses of 10E7 NTCD spores and group C (N=4) will receive 5 doses of placebo.
Depending on the outcome of phase 1, the dose given in phase 2 will either be reduced (if colonisation frequency in phase 1 is >60%), or the doses will be preceded by vancomycin pre-treatment (if the colonisation frequency in phase 1 is <60%) according to predefined criteria. There are three dosing options for phase 2: for the first two options (reduced doses of NTCD) 26 volunteers will be divided over 3 groups group D (N=10), group E (N=10) and the control group F (N=6), for the third option (vancomycin pre-treatment) 23 volunteers will be divided over 3 groups; group D (N=10), group E (N=10) and the control group F (N=3). For the dosing schedules of the three options op the second phase please refer to the section below 'Arms and Interventions'.
Escalation to the third phase will only be done if option 3 is selected in phase 2.Depending on the outcome of phase 2, the dose given in phase 3 will either be reduced (if colonisation frequency in phase 2 is >60%) or the vancomycin pre-treatment will be extended to five days (if the colonisation frequency in phase 2 is <60%) according to predefined criteria. 23 volunteers will be divided over 3 groups: group G (N=10), group H (N=10) and the control group I (N=3). For dosing schedules of the three options of the third phase please refer to the section below 'Arms and Interventions'.
All volunteers in all phases will visit the trial center on the days of spores or placebo ingestion (and if needed also on the first day of vancomycin ingestion), with collection of feces for C.difficile and microbiota analysis before ingestion. During the four follow-up weeks volunteers will visit the trial center three times a week for fecal sample collection (for Cdiff and microbiota analysis), with weekly follow-up visit for AE collection and 2 times a safety blood tests. After three months there will be a final follow-up visit for AEs and fecal sample collection. Should a volunteer still be positive for C.difficile at the three month timepoint, the volunteer is asked to return for follow-up every one to two months for fecal sample collection until the sample is negative for C.difficile, up till a maximum of one year after the start of the trial. Because colonisation with NTCD is very common in the general population, NTCD colonisation will not be terminated with antibiotics. Antibiotic rescue treatment (or in case of persistent disturbances to the host microbiota, a fecal microbiota transplantation) for NTCD is available in case of unexpected adverse events.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- 10E4 NTCD spores, 10E7 NTCD spores, placebo, Vancomycin Oral Capsule
- Keywords
- Colonization
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10E4 NTCD sporesBiological
in capsule for oral ingestion.
10E7 NTCD sporesBiological
in capsule for oral ingestion.
placeboOther
in capsule for oral ingestion.
Vancomycin Oral CapsuleDrug
4 times a day 250mg
| Study group | Role | What they receive |
|---|---|---|
| Group A (phase 1) (N=10) | Experimental | 5 doses of 10E4 NTCD spores on day 0-4. Receives: Biological: 10E4 NTCD spores |
| Group B (phase 1) (N=10) | Experimental | 5 doses of 10E7 NTCD spores on day 0-4. Receives: Biological: 10E7 NTCD spores |
| Group C (phase 1) (N=4) | Placebo comparator | 5 doses of placebo on day 0-4. Receives: Other: placebo |
| Group D (phase 2) (N=10) | Experimental | Based upon the colonisation results of phase 1, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all three groups in phase 2:
* Option 1: 3 doses of 10E4 NTCD spores on day 0-2.
* Option 2: 3 doses of 10E7 NTCD spores on day 0-2.
* Option 3: 1 day of vancomycin on day -7, followed by 5 doses of 10E4 NTCD spores on day 0-4. Receives: Biological: 10E4 NTCD spores; Biological: 10E7 NTCD spores; Drug: Vancomycin Oral Capsule |
| Group E (phase 2) (N=10) | Experimental | Based upon the colonisation results of phase 1, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all three groups in phase 2:
* Option 1: 1 dose of 10E4 NTCD spores on day 0, and 2 doses of placebo on day 1-2.
* Option 2: 1 dose of 10E7 NTCD spores on day 0, and 2 doses of placebo on day 1-2.
* Option 3: 1 day vancomycin on day -7 followed by 5 doses of 10E7 NTCD spores on day 0-4. Receives: Biological: 10E4 NTCD spores; Biological: 10E7 NTCD spores; Other: placebo; Drug: Vancomycin Oral Capsule |
| Group F (phase 2) (N=3 or 6) | Placebo comparator | Based upon the colonisation results of phase 1, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups:
* Option 1 (N=6): 3 doses of placebo on day 0-2.
* Option 2 (N=6): 3 doses of placebo on day 0-2.
* Option 3 (N=3): 1 day vancomycin on day -7, followed by 5 doses of placebo on day 0-4. Receives: Other: placebo; Drug: Vancomycin Oral Capsule |
| Group G (phase 3) (N=10) | Experimental | Escalation to the third phase will only be done if option 3 is selected in phase 2. Based upon the colonisation results of phase 2, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups in phase 3:
* Option 1: 1 day vancomycin on day -7, followed by 3 doses of 10E4 NTCD spores on day 0-2.
* Option 2: 1 day vancomycin on day -7, followed by 3 doses of 10E7 NTCD spores on day 0-2.
* Option 3: 5 days of vancomycin on day -11 until day -7, followed by 5 doses of 10E4 NTCD spores on day 0-4. Receives: Biological: 10E4 NTCD spores; Biological: 10E7 NTCD spores; Drug: Vancomycin Oral Capsule |
| Group H (phase 3) (N=10) | Experimental | Escalation to the third phase will only be done if option 3 is selected in phase 2. Based upon the colonisation results of phase 2, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups in phase 3:
* Option 1: 1 day of vancomycin on day -7, followed by 1 dose of 10E4 NTCD spores on day 0, and 2 doses of placebo on day 1-2.
* Option 2: 1 day of vancomycin on day -7, followed by 1 dose of 10E7 NTCD spores on day 0 and 2 doses of placebo on day 1-2.
* Option 3: 5 days of vancomycin on day -11 until day -7, followed by 5 doses of 10E7 NTCD spores on day 0-4. Receives: Biological: 10E4 NTCD spores; Biological: 10E7 NTCD spores; Other: placebo; Drug: Vancomycin Oral Capsule |
| Group I (phase 3) (N=3) | Placebo comparator | Escalation to the third phase will only be done if option 3 is selected in phase 2. Based upon the colonisation results of phase 2, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups in phase 3:
* Option 1: 1 day of vancomycin on day -7, followed by 3 doses of placebo on day 0-2.
* Option 2: 1 day of vancomycin on day -7, followed by 3 doses of placebo on day 0-2.
* Option 3: 5 days of vancomycin on day -11 until day -7, followed by 5 doses of placebo on day 0-4. Receives: Other: placebo; Drug: Vancomycin Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of colonisation with non-toxigenic C.difficile
Number and grade of related adverse events from day 1 to 28 after ingestion of NTCD spores.
Measured: During the first month after ingestion of NTCD spores.
To establish the effective protocol to obtain colonisation with non-toxigenic C. difficile in the majority of subjects.
The number of volunteers successfully colonised with non-toxigenic C.difficile. Colonisation is defined as a positive PCR for C.difficile on stool or a positive culture for C.difficile on at least two timepoints between three days and two weeks after the last exposure day.
Measured: During the first month after ingestion of NTCD spores.
Secondary outcomes (1)
To determine factors in the host microbiota associated with successful colonisation.
Microbiota markers which are associated with successful C.difficile colonisation through microbiota analysis with 16S amplicon sequencing.
Measured: 3 months after ingestion of NTCD spores.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start22 Sep 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridioides Difficile InfectionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial consists of two or, if necessary, three consecutive intervention phases with each three parallel intervention arms. The first phase consists 24 volunteers, the second phase of 23 or 26 volunteers, and the optional third phase of another 23 volunteers. The volunteers will be divided over three intervention arms.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meta Roestenberg, Leiden University Medical Center
- Investigators
- Meta Roestenberg, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693077
- Sponsor's protocol ID
- CloDiCo
- Acronym
- CloDiCo
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2022
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Colonisation With Non-toxigenic Clostridioides Difficile in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05693077
- Acronym / sponsor ID
- CloDiCo / CloDiCo
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Colonization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 20 Jan 2023 (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.
This study will investigate experimental colonisation with non-toxigenic C.difficile (NTCD) in healthy volunteers. Main outcomes will be safety, tolerability, dose needed to obtain colonisation with NTCD to ultimately determine host microbiota factors associated with susceptibility to colonisation.
Detailed description
This will be an adaptive dose design, randomized double-blind controlled clinical trial investigating oral exposure to NTCD spores in healthy volunteers. The trial will consist of two or, if necessary, three different consecutive intervention phases. The second and third phase are dependent on results of the preliminary phases. In every phase one cohort volunteers will be randomized to different dose levels of NTCD spores or placebo.
50 to 70 healthy volunteers will be included, of which in total 10 volunteers will be exposed to placebo.
The first phase will consist of 24 volunteers, randomized in three groups: group A (N=10) will receive 5 doses of 10E4 NTCD spores, group B (N=10) will receive 5 doses of 10E7 NTCD spores and group C (N=4) will receive 5 doses of placebo.
Depending on the outcome of phase 1, the dose given in phase 2 will either be reduced (if colonisation frequency in phase 1 is >60%), or the doses will be preceded by vancomycin pre-treatment (if the colonisation frequency in phase 1 is <60%) according to predefined criteria. There are three dosing options for phase 2: for the first two options (reduced doses of NTCD) 26 volunteers will be divided over 3 groups group D (N=10), group E (N=10) and the control group F (N=6), for the third option (vancomycin pre-treatment) 23 volunteers will be divided over 3 groups; group D (N=10), group E (N=10) and the control group F (N=3). For the dosing schedules of the three options op the second phase please refer to the section below 'Arms and Interventions'.
Escalation to the third phase will only be done if option 3 is selected in phase 2.Depending on the outcome of phase 2, the dose given in phase 3 will either be reduced (if colonisation frequency in phase 2 is >60%) or the vancomycin pre-treatment will be extended to five days (if the colonisation frequency in phase 2 is <60%) according to predefined criteria. 23 volunteers will be divided over 3 groups: group G (N=10), group H (N=10) and the control group I (N=3). For dosing schedules of the three options of the third phase please refer to the section below 'Arms and Interventions'.
All volunteers in all phases will visit the trial center on the days of spores or placebo ingestion (and if needed also on the first day of vancomycin ingestion), with collection of feces for C.difficile and microbiota analysis before ingestion. During the four follow-up weeks volunteers will visit the trial center three times a week for fecal sample collection (for Cdiff and microbiota analysis), with weekly follow-up visit for AE collection and 2 times a safety blood tests. After three months there will be a final follow-up visit for AEs and fecal sample collection. Should a volunteer still be positive for C.difficile at the three month timepoint, the volunteer is asked to return for follow-up every one to two months for fecal sample collection until the sample is negative for C.difficile, up till a maximum of one year after the start of the trial. Because colonisation with NTCD is very common in the general population, NTCD colonisation will not be terminated with antibiotics. Antibiotic rescue treatment (or in case of persistent disturbances to the host microbiota, a fecal microbiota transplantation) for NTCD is available in case of unexpected adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- The trial consists of two or, if necessary, three consecutive intervention phases with each three parallel intervention arms. The first phase consists 24 volunteers, the second phase of 23 or 26 volunteers, and the optional third phase of another 23 volunteers. The volunteers will be divided over three intervention arms.
| Arm | Type | Receives |
|---|---|---|
| Group A (phase 1) (N=10) | Experimental | Biological: 10E4 NTCD spores5 doses of 10E4 NTCD spores on day 0-4. |
| Group B (phase 1) (N=10) | Experimental | Biological: 10E7 NTCD spores5 doses of 10E7 NTCD spores on day 0-4. |
| Group C (phase 1) (N=4) | Placebo comparator | Other: placebo5 doses of placebo on day 0-4. |
| Group D (phase 2) (N=10) | Experimental | Biological: 10E4 NTCD spores, Biological: 10E7 NTCD spores, Drug: Vancomycin Oral CapsuleBased upon the colonisation results of phase 1, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all three groups in phase 2: * Option 1: 3 doses of 10E4 NTCD spores on day 0-2. * Option 2: 3 doses of 10E7 NTCD spores on day 0-2. * Option 3: 1 day of vancomycin on day -7, followed by 5 doses of 10E4 NTCD spores on day 0-4. |
| Group E (phase 2) (N=10) | Experimental | Biological: 10E4 NTCD spores, Biological: 10E7 NTCD spores, Other: placebo, Drug: Vancomycin Oral CapsuleBased upon the colonisation results of phase 1, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all three groups in phase 2: * Option 1: 1 dose of 10E4 NTCD spores on day 0, and 2 doses of placebo on day 1-2. * Option 2: 1 dose of 10E7 NTCD spores on day 0, and 2 doses of placebo on day 1-2. * Option 3: 1 day vancomycin on day -7 followed by 5 doses of 10E7 NTCD spores on day 0-4. |
| Group F (phase 2) (N=3 or 6) | Placebo comparator | Other: placebo, Drug: Vancomycin Oral CapsuleBased upon the colonisation results of phase 1, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups: * Option 1 (N=6): 3 doses of placebo on day 0-2. * Option 2 (N=6): 3 doses of placebo on day 0-2. * Option 3 (N=3): 1 day vancomycin on day -7, followed by 5 doses of placebo on day 0-4. |
| Group G (phase 3) (N=10) | Experimental | Biological: 10E4 NTCD spores, Biological: 10E7 NTCD spores, Drug: Vancomycin Oral CapsuleEscalation to the third phase will only be done if option 3 is selected in phase 2. Based upon the colonisation results of phase 2, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups in phase 3: * Option 1: 1 day vancomycin on day -7, followed by 3 doses of 10E4 NTCD spores on day 0-2. * Option 2: 1 day vancomycin on day -7, followed by 3 doses of 10E7 NTCD spores on day 0-2. * Option 3: 5 days of vancomycin on day -11 until day -7, followed by 5 doses of 10E4 NTCD spores on day 0-4. |
| Group H (phase 3) (N=10) | Experimental | Biological: 10E4 NTCD spores, Biological: 10E7 NTCD spores, Other: placebo, Drug: Vancomycin Oral CapsuleEscalation to the third phase will only be done if option 3 is selected in phase 2. Based upon the colonisation results of phase 2, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups in phase 3: * Option 1: 1 day of vancomycin on day -7, followed by 1 dose of 10E4 NTCD spores on day 0, and 2 doses of placebo on day 1-2. * Option 2: 1 day of vancomycin on day -7, followed by 1 dose of 10E7 NTCD spores on day 0 and 2 doses of placebo on day 1-2. * Option 3: 5 days of vancomycin on day -11 until day -7, followed by 5 doses of 10E7 NTCD spores on day 0-4. |
| Group I (phase 3) (N=3) | Placebo comparator | Other: placebo, Drug: Vancomycin Oral CapsuleEscalation to the third phase will only be done if option 3 is selected in phase 2. Based upon the colonisation results of phase 2, there are three dosing options for this group, one of the three options will be chosen, the chosen option number will be congruent for all of the groups in phase 3: * Option 1: 1 day of vancomycin on day -7, followed by 3 doses of placebo on day 0-2. * Option 2: 1 day of vancomycin on day -7, followed by 3 doses of placebo on day 0-2. * Option 3: 5 days of vancomycin on day -11 until day -7, followed by 5 doses of placebo on day 0-4. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject is aged ≥ 18 and ≤ 45 years and in good health.
- Subject has adequate understanding of the procedures of the study and is able and willing to abide strictly thereby.
- For female subjects: subject agrees to use adequate contraception and not to breastfeed for the duration of study.
- Subject has signed informed consent.
Key exclusion criteria (14 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any physical or psychiatric illness or conditions that could threaten or compromise the health of the subject during the study, influence their ability to participate in the trial or interfere with the interpretation of the study results, as determined by the trial physician.
- Use of antibiotics (or other microbiota influencing products) within one month prior to inclusion.
- Known immunosuppressive condition, including infection with Human Immunodeficiency Virus (HIV), use of systemic corticosteroids or other immune modifying drugs (with exception of antihistamines and topical steroids).
- Regular use (defined by more than once weekly) of proton-pump inhibitors or H2- blockers during one month prior to inclusion.
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 |
|---|---|---|
| 10E4 NTCD sporesin capsule for oral ingestion. | Biological | Group A (phase 1) (N=10), Group D (phase 2) (N=10), Group E (phase 2) (N=10), Group G (phase 3) (N=10), Group H (phase 3) (N=10) |
| 10E7 NTCD sporesin capsule for oral ingestion. | Biological | Group B (phase 1) (N=10), Group D (phase 2) (N=10), Group E (phase 2) (N=10), Group G (phase 3) (N=10), Group H (phase 3) (N=10) |
| placeboin capsule for oral ingestion. | Other | Group C (phase 1) (N=4), Group E (phase 2) (N=10), Group F (phase 2) (N=3 or 6), Group H (phase 3) (N=10), Group I (phase 3) (N=3) |
| Vancomycin Oral Capsule4 times a day 250mg | Drug | Group D (phase 2) (N=10), Group E (phase 2) (N=10), Group F (phase 2) (N=3 or 6), Group G (phase 3) (N=10), Group H (phase 3) (N=10), Group I (phase 3) (N=3) |
Primary outcome
Safety and tolerability of colonisation with non-toxigenic C.difficile
Time frame: During the first month after ingestion of NTCD spores.
Number and grade of related adverse events from day 1 to 28 after ingestion of NTCD spores.
To establish the effective protocol to obtain colonisation with non-toxigenic C. difficile in the majority of subjects.
Time frame: During the first month after ingestion of NTCD spores.
The number of volunteers successfully colonised with non-toxigenic C.difficile. Colonisation is defined as a positive PCR for C.difficile on stool or a positive culture for C.difficile on at least two timepoints between three days and two weeks after the last exposure day.
1 secondary outcome
To determine factors in the host microbiota associated with successful colonisation.
Time frame: 3 months after ingestion of NTCD spores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- 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.
Meta Roestenberg, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 10E4 NTCD spores, 10E7 NTCD spores and Vancomycin Oral Capsule in people with Clostridioides Difficile Infection, run by Leiden University Medical Center at 1 site in Netherlands.
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 14 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meta Roestenberg, MD, PhD (+31715262102, M.Roestenberg@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of colonisation with non-toxigenic C.difficile (time frame: During the first month after ingestion of NTCD spores.). 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 17 Oct 2023; AzTrials last refreshed its copy on 28 Oct 2026.