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

Nova Southeastern University (NSU)

Status and phase: Enrolling; Phase 2

Conditions: IBS - Irritable Bowel Syndrome; ME/CFS

Treatments: Drug: Floradapt Intensive GI; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06211062

2020-631

Details and patient eligibility

About

This clinical study aims to evaluate the use of i3.1 probiotic in participants who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with irritable bowel syndrome (IBS). The main questions it aims to answer are:

• how effective is the usage of the i3.1 probiotic to reduce gastrointestinal (GI) inflammation and normalize the GI and systemic/brain interface?
• how well is it working on IBS severity? The study sample is 100 male and female participants aged 45 to 70 years with ME/CFS (per the Canadian Consensus Criteria); one-half of the participants will have co-morbid IBS (per Rome IV criteria). Participants will receive an i3.1 or a placebo and be assessed at baseline, at eight weeks, and at 12 weeks (four weeks post-treatment completion).

Full description

This single-site comparison study will be performed on 100 participants, 45 to 70 years of age, who meet the Institute of Medicine (Canadian Consensus Criteria) case definition for ME/CFS and who may or may not be diagnosed with the irritable bowel syndrome (IBS), according to the Rome IV criteria. In this study, we will evaluate using the i3.1 probiotic compared to placebo. This is a randomized, placebo-controlled trial with four study arms that will include 25 participants per arm: Individuals with ME/CFS with and without IBS, who will take either the active medication i3.1 or placebo.

Enrollment: 100 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: eligible if all of the following apply:

• Meets IOM ME/CFS case definition criteria,
• Co-morbid IBS: meets RomeIV criteria for alternating or diarrhea-predominant IBS as reported during screening (technically diagnosed by a physician),
• Able to provide consent to study,
• Patients of childbearing potential must practice effective contraception during the study and be willing to continue contraception for at least six months after the intervention,
• agrees to participate in online surveys and follow-up visits.

Exclusion Criteria: ineligible if any of the following apply:

• Probiotics in the past eight weeks,
• Antibiotics in the past eight weeks,
• Pregnancy or lactating women,
• 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,
• History of psychiatric disorder, alcohol or illicit drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Individuals with ME/CFS with IBS on active medication

Active Comparator group

Description:

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.

Treatment:

Drug: Floradapt Intensive GI

Individuals with ME/CFS with IBS on placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Individuals with ME/CFS without IBS on active medication

Active Comparator group

Description:

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.

Treatment:

Drug: Floradapt Intensive GI

Individuals with ME/CFS without IBS on placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo