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Probiotic

Probiotics for Small Intestinal Bacterial Overgrowth

N/A
Recruiting
Research Sponsored by Nimble Science Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if a probiotic can help reduce bloating and abdominal distension in people with Small Intestinal Bacterial Overgrowth compared to a placebo. They will also look at other digestive

Who is the study for?
This trial is for individuals experiencing bloating and abdominal distension due to Small Intestinal Bacterial Overgrowth (SIBO). Participants should be diagnosed with SIBO. The study excludes those who do not meet the specific medical criteria required, which are not detailed here.
What is being tested?
The study tests a probiotic formula against a placebo to see if it can reduce gastrointestinal symptoms like bloating in people with SIBO. It also looks at how this treatment affects the overall gut microbiome using an innovative capsule called SIMBA.
What are the potential side effects?
While side effects are not explicitly listed, probiotics typically may cause mild digestive symptoms such as gas or bloating initially, but serious side effects are rare.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in bloating/distension severity
Secondary study objectives
Change in SIBO positivity rate
Change in abdominal discomfort/pain
Change in median bloating/distension severity
+9 more
Other study objectives
Exploratory metabolomic analysis
Exploratory: Quantifying the probiotic cell proportions
Safety outcomes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Probiotic (Low dose)Experimental Treatment1 Intervention
A low dosage probiotic per capsule
Group II: Probiotic (High dose)Experimental Treatment1 Intervention
A high dosage probiotic per capsule
Group III: Control group (Placebo)Active Control1 Intervention
No probiotic dosage
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570

Find a Location

Who is running the clinical trial?

Nimble Science Ltd.Lead Sponsor
7 Previous Clinical Trials
400 Total Patients Enrolled
Lallemand Health SolutionsIndustry Sponsor
41 Previous Clinical Trials
3,871 Total Patients Enrolled
~0 spots leftby Dec 2024
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