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Probiotic

Probiotics for Chronic Fatigue 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

Must not have

Medical conditions including short bowel syndrome, celiac disease, biliary disease, pancreatitis, inflammatory bowel disease (Crohn's disease, ulcerative colitis), severe cardiovascular, neurological condition, or liver failure

Gastrointestinal surgery within six months of study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to the eight week visit

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe digestive, heart, brain, or liver conditions.

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I have not had any gastrointestinal surgery in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the eight week visit to the 12 week visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 / 3Eligibility criteria met