Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis

NCT07318129 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-01-28

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07318129 on ClinicalTrials.gov