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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
C. difficile colonization
C.difficile colonization
Presence and levels of C. difficile toxin in fecal samples
+2 moreOther outcome measures
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
584 Total Patients Enrolled
Estimates OYUNKNOWN
Novozymes A/SLead Sponsor
12 Previous Clinical Trials
840 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration currently open for participation in this research project?
"Unfortunately, according to clinicaltrials.gov this particular medical trial is not currently recruiting patients. The study was first posted on the 1st of January 2023 and recently modified on October 31, 2022. However, 1793 other trials are actively seeking volunteers at present time."
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