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Probiotic

Individuals with ME/CFS with IBS on active medication for Irritable Bowel Syndrome

Phase 2

Recruiting

Led By Nancy Klimas, MD

Research Sponsored by Nova Southeastern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets IOM ME/CFS case definition criteria

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the eight week visit to the 12 week visit

Awards & highlights

Study Summary

This trial aims to test the effectiveness of a probiotic called i3.1 in reducing inflammation in the gut and improving symptoms of irritable bowel syndrome (IBS) in individuals with ME/CFS

Who is the study for?

This trial is for men and women aged 45-70 with ME/CFS as defined by the Canadian Consensus Criteria. It's also open to those who may have IBS according to Rome IV criteria. Participants should not be part of any other studies or have conditions that could interfere with this trial.Check my eligibility

What is being tested?

The study tests if a probiotic called i3.1 can reduce GI inflammation and improve brain-GI system interaction in ME/CFS patients, some with IBS. Half will receive the probiotic, half a placebo, over an eight-week period followed by assessments.See study design

What are the potential side effects?

Probiotics like i3.1 are generally considered safe but may cause digestive discomfort such as gas or bloating initially, especially in individuals with sensitive stomachs or pre-existing GI issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with ME/CFS according to IOM criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to the eight week visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to the eight week visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to the eight week visit for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The Incidence of Intervention-Related Adverse Events [Safety]

The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy]

The Symptom Severity Measurement [Efficacy]

+2 more

Secondary outcome measures

The IBS-related Quality of Life Measurement

The Impact on the Irritable Bowel Syndrome (IBS) Severity

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Individuals with ME/CFS with IBS on active medicationActive Control1 Intervention

Individuals with ME/CFS with IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (>3x10 to the ninth power) once daily for eight weeks.

Group II: Individuals with ME/CFS without IBS on active medicationActive Control1 Intervention

Individuals with ME/CFS without IBS take Floradapt Intensive GI (another name i3.1), one high dose capsule (>3x10 to the ninth power) once daily for eight weeks.

Group III: Individuals with ME/CFS with IBS on placeboPlacebo Group1 Intervention

Individuals with ME/CFS with IBS take a placebo, one capsule once daily for eight weeks.

Group IV: Individuals with ME/CFS without IBS on placeboPlacebo Group1 Intervention

Individuals with ME/CFS without IBS take a placebo, one capsule once daily for eight weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor

89 Previous Clinical Trials

11,541 Total Patients Enrolled

Nancy Klimas, MDPrincipal InvestigatorNova Southeastern University, Institute for Neuroimmune Medicine

4 Previous Clinical Trials

262 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, as per the details provided on clinicaltrials.gov, this trial is presently in the active recruitment phase. The initial posting of this clinical trial took place on December 20th, 2022, and it was last modified on January 17th, 2024."

Answered by AI

Are individuals above the age of 25 eligible to participate in this study's patient recruitment process?

"To be eligible for participation in this clinical trial, individuals must meet the age requirements of being at least 45 years old and no older than 70."

Answered by AI

What is the upper limit for the total number of individuals involved in this medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this specific clinical trial is actively seeking participants. The study was initially posted on December 20th, 2022 and the most recent update occurred on January 17th, 2024. A total of 100 individuals are being recruited from a single site for this trial."

Answered by AI

Are individuals diagnosed with ME/CFS and IBS currently prescribed FDA-approved active medication?

"Our team at Power rates the safety of individuals with ME/CFS and IBS who are on active medication as a 2, considering that this trial is in Phase 2. While there is some supporting data for safety, no evidence has been found yet to support efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

2022. "The Use of Directed Probiotics in ME/CFS: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06211062.

All > Irritable Bowel Syndrome > Chronic Fatigue Syndrome