Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis
NCT07318129 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2026-01-28
Summary
This study, iPROACT-MS, is part of the iPROACT group of clinical trials aiming to investigate the effects of oral supplementation with indole-3-propionic acid (IPA) in humans. IPA is naturally produced as a gut bacterial metabolite with the amino acid tryptophan as substrate. The primary aim of iPROACT-MS is to investigate whether patients with relapsing-remitting multiple sclerosis (RRMS) can benefit from supplementation with IPA. The hypothesis is that supplementation with IPA will protect against MS-related disease activity, neurodegeneration and metabolic abnormalities. Secondary, iPROACT-MS aims at elucidating the complex relationships between lifestyle, gut microbial factors, inflammation, oxidative stress, metabolic health, MS disease severity and MS disease activity.
Conditions
- Relapsing Remitting Multiple Sclerosis (RRMS)
Interventions
- DIETARY_SUPPLEMENT
-
Placebo
Two capsules are taken every morning and two capsules are taken every evening for 27 consecutive months. Placebo capsules are taken orally.
- DIETARY_SUPPLEMENT
-
Indole-3-propionic acid (IPA)
Two capsules are taken every morning and two capsules are taken every evening for 27 consecutive months. Active capsules are taken orally and contain 250 mg of IPA each resulting in a total daily dose of 1000 mg of IPA.
Sponsors & Collaborators
-
University of Copenhagen
collaborator OTHER -
University of Southampton
collaborator OTHER -
Glostrup University Hospital, Copenhagen
lead OTHER
Principal Investigators
-
Jette Lautrup Frederiksen, MD, dr.med, professor · Copenhagen University Hospital, Rigshospitalet-Glostrup
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-26
- Primary Completion
- 2028-07-15
- Completion
- 2028-07-15
Countries
- Denmark
Study Locations
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