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Probiotic

Probiotic (Low dose) for Small Intestinal Bacterial Overgrowth

N/A

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in bloating/distension severity

Secondary outcome measures

Change in SIBO positivity rate

Change in abdominal discomfort/pain

Change in median bloating/distension severity

+9 more

Other outcome measures

Exploratory metabolomic analysis

Exploratory: Quantifying B. subtilis cell proportions

Safety outcomes

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Probiotic (Low dose)Experimental Treatment1 Intervention

A high dosage probiotic per capsule

Group II: Probiotic (High dose)Experimental Treatment1 Intervention

A low 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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Nimble Science Ltd.Lead Sponsor

6 Previous Clinical Trials

380 Total Patients Enrolled

Lallemand Health SolutionsIndustry Sponsor

40 Previous Clinical Trials

3,684 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be considered the ideal candidates to enroll in this research study?

"Candidates aged between 18 and 55 with a diagnosis of small intestinal bacterial overgrowth are eligible for participation in this research study, which has availability for up to 105 participants."

Answered by AI

Can individuals younger than 25 years old participate in this research trial?

"Eligible participants for this research study must fall within the age bracket of 18 to 55. There is a separate trial designated for individuals below 18 years old and another two trials catering to those above 65 years of age."

Answered by AI

Are new participants currently being accepted for enrollment in this ongoing medical study?

"As stated on clinicaltrials.gov, this particular research study is no longer seeking volunteers. The trial was initially listed on May 1st, 2024 and the last update was made on March 11th, 2024. Despite the closure of this trial, there are presently five alternative studies welcoming new participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms

2024. "The Safety and Efficacy of a Probiotic Intervention on SIBO and Related Gastrointestinal Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06317441.

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