RecruitingNot ApplicableNCT07318129

Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis

Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis (iPROACT-MS)

Sponsor

Glostrup University Hospital, Copenhagen

Enrollment

220 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Relapsing-remitting Multiple Sclerosis (RRMS)

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria9

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

Interventions

DIETARY_SUPPLEMENTPlacebo

Two capsules are taken every morning and two capsules are taken every evening for 27 consecutive months. Placebo capsules are taken orally.

DIETARY_SUPPLEMENTIndole-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.