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

RecruitingNot a drug-phase studyRelapsing MSNCT07318129

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Riboprine

Placebo

  • Placebo

What it measured

Main measures

  • No evidence of disease activity (NEDA)

    The time between month 3 and month 27 after initiation of supplementation.

    Disability progressionRelapsesMRI lesions

Other measures (25)

  • Annualized relapse rate evaluated at month 27

    The time between month 3 and month 27 after initiation of supplementation.

    Relapses
  • Total (cumulative) number of new or enlarged T2-weighted/FLAIR brain lesions per scheduled yearly MRI evaluated at month 27

    The time between month 3 and month 27 after initiation of supplementation.

    MRI lesions
  • Serum neurofilament light chain (sNfL)

    Evaluated longitudinally at months 0, 3, 15 and 27.

    Blood or spinal fluid markers
  • Percentage of patients with disability improvement confirmed at 3 months

    The time between month 3 and month 27 after initiation of supplementation.

    Disability progression
  • The time to onset of disability worsening confirmed at 3 months

    The time between month 3 and month 27 after initiation of supplementation.

    Disability progressionRelapses
  • Cumulative change in EDSS score

    The time between month 3 and month 24 after initiation of supplementation.

    Disability progressionHow the body handles the medicine
  • Multiple Sclerosis Functional Composite (MSFC)

    The time between month 0 and month 24 after initiation of supplementation.

    Disability progressionThinking and memoryWalking and mobility
  • Symbol Digit Modalities Test (SDMT)

    The time between month 0 and month 24 after initiation of supplementation.

    Thinking and memory
  • California Verbal Learning Test-II (CVLT-II)

    The time between month 0 and month 24 after initiation of supplementation.

    Thinking and memory
  • Brief Visuospatial Memory Test - Revised (BVMR-R)

    The time between month 0 and month 24 after initiation of supplementation.

    Thinking and memory

Who could take part

Relapsing MS · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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History

  1. Result signal changed from Ongoing to Results published
  1. Started

    Jan 2026

  2. Main results due

    Jul 2028

  3. Finished

    Jul 2028

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