NCT07753122 Controlled Trial of Hydrogen Water as a Treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
| NCT ID | NCT07753122 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fred Friedberg |
| Condition | Chronic Fatigue Syndrome (CFS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-08-15 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-08-15 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a 16-week controlled treatment trial of an over-the -counter supplement, hydrogen water, for individuals with ME/CFS patients. An active treatment condition will be compared to a placebo-control condition. The study will also seek confirmation of heart rate variability (HRV) as a biomarker, that is, as a predictor of improvement vs. non-improvement to be assessed at treatment termination. The HRV biomarker hypothesis is based on a finding that High Frequency HRV (cardio-parasympathetic measure) biologically separated improvers and non-improvers in my previous ME/CFS observational study.
Eligibility Criteria
Inclusion Criteria: * Patients aged 18-65 of both sexes * considered physically capable and willing to perform the study tasks * Meet validated phone-screen eligibility for ME/CFS criteria * Participant has internet and computer Exclusion Criteria: * Cases of fatigue clearly attributable to self-report medical conditions such as untreated hypothyroidism, unstable diabetes mellitus, organ failure, chronic infections, and chronic inflammatory diseases, or AIDS. Kidney disease/renal failure is also an exclusion * Exclusionary psychiatric disorders include any psychosis, or alcohol/ substance abuse within two years prior to illness onset and any time afterward, and current or past depression with melancholic or psychotic features within 5 years prior to onset of ME/CFS or anytime afterward * Pregnancy is an exclusion. * Patients with BMI\>35 \_\_\_\_Patients regularly taking therapeutic magnesium. * Patients at significant risk of suicide or in need of urgent psychiatric treatment. As much as possible, appropriate medical and psychiatric referrals to facilities local to subjects will be provided.
Contact & Investigator
Fred Friedberg, PhD
PRINCIPAL INVESTIGATOR
Stony Brook University
Frequently Asked Questions
Who can join the NCT07753122 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Fatigue Syndrome (CFS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07753122 currently recruiting?
Yes, NCT07753122 is actively recruiting participants. Contact the research team at Fred.Friedberg@stonybrookmedicine.edu for enrollment information.
Where is the NCT07753122 trial being conducted?
This trial is being conducted at Stony Brook, United States.
Who is sponsoring the NCT07753122 clinical trial?
NCT07753122 is sponsored by Fred Friedberg. The principal investigator is Fred Friedberg, PhD at Stony Brook University. The trial plans to enroll 80 participants.