Indole-3-propionic acid supplementation for relapsing-remitting MS
Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis (iPROACT-MS)
This trial tests whether taking oral indole-3-propionic acid (a gut-derived supplement) can help protect people with relapsing‑remitting MS from disease activity, nerve damage, and related metabolic problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Glostrup University Hospital, Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT07318129 on ClinicalTrials.gov |
What this trial studies
This interventional trial gives adults with relapsing‑remitting MS daily oral indole‑3‑propionic acid (IPA) or a matching placebo while monitoring clinical and biological outcomes. Participants undergo clinical follow-up, MRI scans, and laboratory tests to track MS disease activity, neurodegeneration markers, inflammation, oxidative stress, metabolic measures, and gut microbiome profiles. Secondary analyses will examine how lifestyle and gut microbial factors relate to inflammation, metabolic health, and MS severity. The trial is led at Glostrup Hospital in collaboration with the University of Copenhagen and the University of Southampton.
Who should consider this trial
Good fit: Adults aged 18–65 with relapsing‑remitting MS by McDonald criteria who are routinely treated and monitored for MS and can read and speak Danish are the intended participants.
Not a fit: People with progressive MS, active malignancy, inflammatory bowel disease, significant comorbidities, pregnancy or lactation, or MR contraindications are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, IPA supplementation could reduce MS relapses and slow neurodegeneration while improving metabolic and inflammatory profiles.
How similar studies have performed: Preclinical studies and small human investigations of IPA and related gut-derived metabolites suggest neuroprotective and anti‑inflammatory effects, but oral IPA supplementation in RRMS remains largely untested in larger clinical trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women and men ≥18 and ≤65 years of age * Diagnosed with RRMS according to the 2017 McDonald criteria (or newer updates) * Routinely treated and monitored for MS * Speak and read Danish * Deemed physically and mentally able to participate in this study Exclusion Criteria: * Active malignancy * Diagnosis of Crohn's disease and ulcerative colitis * Other comorbidities deemed to be relevant * Haematopoietic stem cell transplantation * Current or past treatment with non-MS related treatments deemed to be relevant * Pregnancy or lactation * People with MR contraindications: * Severe claustrophobia * Incompatible implants/ foreign objects, including implanted pacemakers, heart valve prostheses, prostheses in the middle ear, implanted devices (e.g., insulin pump), metal debris, e.g., metal splinters in the eyes, miscellaneous shunts and catheters, metal clips from operations
Where this trial is running
Glostrup Municipality
- Glostrup Hospital — Glostrup Municipality, Denmark (Recruiting)
Study contacts
- Principal investigator: Jette Lautrup Frederiksen, MD, dr.med, professor — Copenhagen University Hospital, Rigshospitalet-Glostrup
- Study coordinator: Jette Lautrup Frederiksen, MD, dr.med, professor
- Email: jette.lautrup.battistini@regionh.dk
- Phone: +4538633041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.