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Clostridium Difficile Infection RecurrenceNCT05606159

Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections

A study testing Bacillus velezensis DSM 33864 in people with Clostridium Difficile Infection Recurrence, run by Novozymes A/S at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to determine whether a single strain capsulated probiotic, when used after standard C. difficile antibiotic therapy, is effective in reducing the risk of infection recurrence mediated by a decrease in colonization by toxigenic C. difficile. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Bacillus velezensis DSM 33864
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2023to Dec 2024
Phase
Interventional
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

Who may be able to join

  • Males and females ≥ 18 years old
  • Medical record documentation of second or subsequent recurrent CDI episode, and received standard-of-care oral antibiotic therapy completed no more than 5 days prior date of enrollment.
  • Able to provide signed and dated informed consent or assent
  • Able to provide blood and fecal specimens

Who cannot join

  • Current episode of CDI or delayed symptom resolution from previous reoccurrence (second episode), according to the physical exam and investigator assessment
  • Pregnancy or breastfeeding
  • Subjects presenting with active diarrhea (3 or more stools per 24-hour period) and within Bristol stool scale range of 5-7
  • Taking dietary supplement or therapeutic intervention which could significantly affect parameter(s) followed during the study (fibers, probiotics, prebiotics, symbiotic) according to the investigator or stopped in a too short period before the V1 visit (< 4 weeks)
  • Previous reaction, including anaphylaxis, to any substance in composition of the study product
  • Active, non-controlled intestinal disease such as Crohn's Disease, ulcerative colitis; celiac disease, or other chronic diarrheal illness
Show all 11Show fewer
  • Patients with active Pancreatitis
  • Ostomized subjects, parenteral nutrition users
  • Under immunosuppressive therapy or any health condition causing immunosuppression (including active hematological malignancies, acquired immune deficiency syndrome (AIDS), recent solid organ transplant (within 90 days),under treatment for rejection
  • For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study or menopausal without or with hormone replacement therapy (estrogenic replacement therapy begun from less than 3 months excluded);
  • Pregnant or lactating women or intending to become pregnant within 3 months ahead

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beaumont Hospital

    Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Tolerability and Effect of Bacillus Velezensis DSM 33864 on the Reduction of Risk of Recurrent Clostridioides Difficile Infection (rCDI) in Adults With a History of rCDI

The purpose of this study is to determine whether a single strain capsulated probiotic, when used after standard C. difficile antibiotic therapy, is effective in reducing the risk of infection recurrence mediated by a decrease in colonization by toxigenic C. difficile. This study will include adults with a history of two episodes of C. difficile infection (CDI).

Read the detailed description

The goal of this multi-center randomized double-blinded placebo-controlled trial is to evaluate the tolerability and effect of a probiotic dietary supplement on the reduction of the risk of recurrent C. difficile infection in adults who have experienced two previous C. difficile infection episodes.

The main aim of this study is to assess the effect of a probiotic dietary supplement on the colonization (cell counts) of C. difficile over time and also to assess the correlation between level of C. difficile colonization and recurrence of CDI.

Approximately, 104 research subjects will be randomized into two arms and will use either one capsule daily of the probiotic supplement or placebo once daily with breakfast, for 8 weeks. All outcomes will be compared across the supplementation and placebo arm.

Being tested
Bacillus velezensis DSM 33864, Placebo
Keywords
Probiotic, Gastrointestinal Microbiota, C. difficile, Dietary supplement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bacillus velezensis DSM 33864Dietary supplement

    Also called Probiotic

    1 probiotic capsule to be taken orally once a day, with breakfast, once a day for 8 weeks.

  • PlaceboDietary supplement

    1 microcrystalline cellulose-containing placebo capsule to be taken orally once a day with breakfast, for 8 weeks.

Study groups in NCT05606159
Study groupRoleWhat they receive
Bacillus velezensis DSM 33864ExperimentalThis arm will receive a single strain probiotic capsule containing Bacillus velezensis DSM 33864. The probiotic will be taken orally, once a day, for 8 weeks.
Receives: Dietary Supplement: Bacillus velezensis DSM 33864
Placebo control groupPlacebo comparatorA placebo capsule containing microcrystalline cellulose will be taken orally, once a day, for 8 weeks.
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C. difficile colonization

    Change in colonization (counts) of toxigenic C. difficile from baseline to 8 weeks determined by quantitative PCR

    Measured: 8 weeks

Secondary outcomes (6)

  1. C. difficile colonization

    Change in colonization (counts) of toxigenic C. difficile determined by quantitative PCR

    Measured: 4 weeks

  2. C.difficile colonization

    Change in colonization (counts) of toxigenic C.difficile determined by quantitative PCR

    Measured: 12 weeks

  3. Presence and levels of C. difficile toxin in fecal samples

    Change in concentration of C. difficile Toxin A or B levels in fecal samples from baseline to week 4, week 8 and week 12 determined by enzyme immune assay method (EIA)

    Measured: 12 weeks

  4. Quality of life assessment

    Change in average health-related quality of life scores at baseline, week 8 and 12, determined by EQ-5D-5L questionnaire

    Measured: 12 weeks

  5. Reduction of the risk of rCDI

    Incidence of rCDI defined as an episode of diarrhea onset described by three or more unformed stools per 24 h as measured by the Bristol stool chart (types 5 to 7), and positive toxin assay result for C. difficile.

    Measured: 8 weeks

  6. Reduction of the risk of rCDI

    Incidence of rCDI defined as an episode of diarrhea onset described by three or more unformed stools per 24 h as measured by the Bristol stool chart (types 5 to 7), and positive toxin assay result for C. difficile.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study startNov 2023 (estimated)
  3. Primary completionNov 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Why it stopped: Research Project closed

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
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled multicenter clinical trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606159
Sponsor's protocol ID
NZ-GHCD-2021-06
Status last verified
Nov 2024
First submitted
9 Aug 2022
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bacillus velezensis DSM 33864 in people with Clostridium Difficile Infection Recurrence, run by Novozymes A/S at 1 site in United States.

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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 22 Nov 2024. 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 United States. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

C. difficile colonization (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05606159.

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 22 Nov 2024.

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