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Probiotics for Clostridium Difficile Infection Recurrence
N/A
Waitlist Available
Led By Matthew Sims, PhD
Research Sponsored by Novozymes A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial studies if taking probiotics after CDI treatment can lower risk of recurrence. Adults with 2 CDI episodes will be included.
Who is the study for?
Adults over 18 who've had at least two bouts of C. difficile infection and finished standard antibiotic treatment within the past 5 days can join. They must be able to consent, provide samples, and not be pregnant or breastfeeding. Those on certain diets or treatments that affect the study, with immune issues, active diarrhea, or chronic intestinal diseases cannot participate.
What is being tested?
The trial is testing Bacillus velezensis DSM 33864—a probiotic—against a placebo to see if it lowers the chance of another C. difficile infection after standard treatment in adults with a history of recurrent infections.
What are the potential side effects?
Potential side effects are not explicitly listed for this probiotic intervention but may include digestive discomfort such as gas or bloating. Placebos typically have no side effects but can cause reactions based on an individual's belief about taking an active substance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
C. difficile colonization
C.difficile colonization
Presence and levels of C. difficile toxin in fecal samples
+2 moreOther study objectives
Body Weight Changes
Fatty Acids, Volatile
Changes in blood C-reactive protein (CRP) levels
+11 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bacillus velezensis DSM 33864Experimental Treatment1 Intervention
This 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.
Group II: Placebo control groupPlacebo Group1 Intervention
A placebo capsule containing microcrystalline cellulose will be taken orally, once a day, for 8 weeks.
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Who is running the clinical trial?
Evidilya S.r.l.UNKNOWN
4 Previous Clinical Trials
293 Total Patients Enrolled
Estimates OYUNKNOWN
Novozymes A/SLead Sponsor
12 Previous Clinical Trials
840 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have severe diarrhea.I am 18 years old or older.I am a woman using reliable contraception for 3 cycles or am menopausal, possibly with hormone therapy started over 3 months ago.I can provide blood and stool samples.I currently have active pancreatitis.I've had at least two C. diff infections and finished antibiotics for it within the last 5 days.I am currently experiencing or have unresolved symptoms from a second episode of C. diff infection.I am under treatment that weakens my immune system or have a condition that does so.I do not have active, unmanaged intestinal conditions like Crohn's or chronic diarrhea.I have not taken supplements or treatments that could affect the study results in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo control group
- Group 2: Bacillus velezensis DSM 33864
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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