Clinical trial

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

ID

Name

2020-631

Description

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).

Trial arms

Trial start

2022-12-20

Estimated PCD

2024-09-01

Trial end

2024-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Floradapt Intensive GI

one capsule daily for the eight week intervention

Arms:

Individuals with ME/CFS with IBS on active medication, Individuals with ME/CFS without IBS on active medication

Other names:

i3.1

Placebo

one capsule daily for the eight week intervention

Arms:

Individuals with ME/CFS with IBS on placebo, Individuals with ME/CFS without IBS on placebo

Size

100

Primary endpoint

The Incidence of Intervention-Related Adverse Events [Safety]

from baseline to the eight week visit

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

from baseline to the eight week visit

level of CRP (C-reactive protein)

from baseline to the eight week visit

The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α

from baseline to the eight week visit

The Symptom Severity Measurement [Efficacy]

from baseline to the eight week visit

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double-blinded', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2024-01-18

1 organization

1 product

2 indications

Organization

Nova Southeastern University

Product

Indication

Indication

IBS - Irritable Bowel Syndrome