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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 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.

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Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor
93 Previous Clinical Trials
11,592 Total Patients Enrolled
Nancy Klimas, MDPrincipal InvestigatorNova Southeastern University, Institute for Neuroimmune Medicine
4 Previous Clinical Trials
262 Total Patients Enrolled
~10 spots leftby Sep 2024
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