Recruiting
Phase 2

Directed Probiotics

Sponsor:

Nova Southeastern University

Code:

NCT06211062

Conditions

ME/CFS

IBS - Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 45 - 70

Healthy Volunteers: Not accepted

Interventions

Floradapt Intensive GI

Placebo

Study Details

Brief summary:

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).

Conditions

ME/CFS

IBS - Irritable Bowel Syndrome

Study ID

NCT06211062

Start date

Dec 20, 2022

Status verified date

Mar, 2025

Completion date

Feb 24, 2026

Anticipated

Primary completion date

Feb 24, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Individuals with ME/CFS with IBS on active medication

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.

placebo comparator: Individuals with ME/CFS with IBS on placebo

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

active comparator: Individuals with ME/CFS without IBS on active medication

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.

placebo comparator: Individuals with ME/CFS without IBS on placebo

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

Interventions

Floradapt Intensive GI

one capsule daily for the eight week intervention

Placebo

one capsule daily for the eight week intervention

Primary outcome measure

  • The Incidence of Intervention-Related Adverse Events [Safety] [ Time Frame: from baseline to the eight week visit ]
  • The Measurement of Biomarker Response to an Intervention in the Blood [Efficacy] [ Time Frame: from baseline to the eight week visit ]
  • level of CRP (C-reactive protein) [ Time Frame: from baseline to the eight week visit ]
  • The pro-inflammatory cytokines level e.g. IL-1, IL-6, and TNF-α [ Time Frame: from baseline to the eight week visit ]
  • The Symptom Severity Measurement [Efficacy] [ Time Frame: from baseline to the eight week visit ]

Central Contacts and Locations

Central contacts

Nancy Klimas, MD

9542622855nklimas@nova.edu

Devra Cohen, MPH

9542621487dcohen1@nova.edu

Locations

Institute for Neuroimmune Medicine

Recruiting

Fort Lauderdale, Florida, United States, 33314-7796

Contacts

Oleksandra Shchebet

954-262-2896kanekastudy@nova.edu

More Information

Sponsor

Nova Southeastern University

Last update posted

Mar 4, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Nova Southeastern University on 2025-03-04.