RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-12-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06211062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Meets IOM ME/CFS case definition criteria,
  2. * Co-morbid IBS: meets RomeIV criteria for alternating or diarrhea-predominant IBS as reported during screening (technically diagnosed by a physician),
  3. * Able to provide consent to study,
  4. * 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,
  5. * agrees to participate in online surveys and follow-up visits.
  1. * Probiotics in the past eight weeks,
  2. * Antibiotics in the past eight weeks,
  3. * Pregnancy or lactating women,
  4. * 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,
  5. * Gastrointestinal surgery within six months of study entry,
  6. * History of psychiatric disorder, alcohol or illicit drug abuse.

Contacts and Locations

Study Contact

Nancy Klimas, MD
CONTACT
9542622855
nklimas@nova.edu
Devra Cohen, MPH
CONTACT
9542621487
dcohen1@nova.edu

Principal Investigator

Nancy Klimas, MD
PRINCIPAL_INVESTIGATOR
Nova Southeastern University, Institute for Neuroimmune Medicine

Study Locations (Sites)

Institute for Neuroimmune Medicine
Fort Lauderdale, Florida, 33314-7796
United States

Collaborators and Investigators

Sponsor: Nova Southeastern University

  • Nancy Klimas, MD, PRINCIPAL_INVESTIGATOR, Nova Southeastern University, Institute for Neuroimmune Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-12-20
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • ME/CFS
  • IBS - Irritable Bowel Syndrome