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Recruiting NCT07318129

Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis

No phase Interventional Relapsing Remitting Multiple Sclerosis (RRMS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo, Indole-3-propionic acid (IPA).
Who it may be relevant to
Registry conditions: Relapsing Remitting Multiple Sclerosis (RRMS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • No evidence of disease activity (NEDA) [Time frame: The time between month 3 and month 27 after initiation of supplementation.]
Secondary outcome measures (12)
  • Annualized relapse rate evaluated at month 27 [Time frame: The time between month 3 and month 27 after initiation of supplementation.]
  • Total (cumulative) number of new or enlarged T2-weighted/FLAIR brain lesions per scheduled yearly MRI evaluated at month 27 [Time frame: The time between month 3 and month 27 after initiation of supplementation.]
  • Serum neurofilament light chain (sNfL) [Time frame: Evaluated longitudinally at months 0, 3, 15 and 27.]
  • Percentage of patients with disability improvement confirmed at 3 months [Time frame: The time between month 3 and month 27 after initiation of supplementation.]
  • The time to onset of disability worsening confirmed at 3 months [Time frame: The time between month 3 and month 27 after initiation of supplementation.]
  • Cumulative change in EDSS score [Time frame: The time between month 3 and month 24 after initiation of supplementation.]
  • Multiple Sclerosis Functional Composite (MSFC) [Time frame: The time between month 0 and month 24 after initiation of supplementation.]
  • Symbol Digit Modalities Test (SDMT) [Time frame: The time between month 0 and month 24 after initiation of supplementation.]
  • California Verbal Learning Test-II (CVLT-II) [Time frame: The time between month 0 and month 24 after initiation of supplementation.]
  • Brief Visuospatial Memory Test - Revised (BVMR-R) [Time frame: The time between month 0 and month 24 after initiation of supplementation.]
  • Intra-eye change in peripapillary retinal nerve fiber layer (RNFL) thickness [Time frame: The time between month 0 and month 24 after initiation of supplementation.]
  • Intra-eye change in ganglion cell and inner plexiform layer (GCIPL) thickness [Time frame: The time between month 0 and month 24 after initiation of supplementation.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Glostrup Hospital — Glostrup Municipality

Identifiers

NCT: NCT07318129 · H-25042489

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗