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Relapsing Remitting Multiple Sclerosis (RRMS)iPROACT-MSNCT07318129

Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis

A study testing Indole-3-propionic acid (IPA) in people with Relapsing Remitting Multiple Sclerosis (RRMS), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Indole-3-propionic acid (IPA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
220 participants
Where
1 siteDenmark
Study dates
26 Jan 2026to 15 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jette Lautrup Frederiksen, MD, dr.med, professor contact

+4538633041

jette.lautrup.battistini@regionh.dk

Moschoula Passali, MSc, PhD contact

+45 38633467

moschoula.passali@regionh.dk

Denmark1 site, 1 recruiting
  • Glostrup Hospital

    Glostrup Municipality, 2600

    Jette Lautrup Frederiksen, MD, dr.med, professor, +45386330, jette.lautrup.battistini@regionh.dk

    Recruiting

Other trials in Denmark

About this study

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

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.

Being tested
Placebo, Indole-3-propionic acid (IPA)
Keywords
indole-3-propionic acid, multiple sclerosis, gut bacterial metabolite, dietary supplement, gut-brain axis
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

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

  • Indole-3-propionic acid (IPA)Dietary supplement

    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.

Study groups in NCT07318129
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo capsules
Receives: Dietary Supplement: Placebo
Indole-3-propionic acid (IPA)ExperimentalIPA capsules
Receives: Dietary Supplement: Indole-3-propionic acid (IPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. No evidence of disease activity (NEDA)

    The percentage of patients that maintain no evidence of disease activity (NEDA-3) in the time between month 3 and month 27 after initiation of supplementation. NEDA-3 is defined as a binary composite consisting of absence of confirmed relapses, no new or enlarged lesions on brain MRI and no confirmed disability progression. For relapses to be confirmed, they need to be accompanied by an increase of at least 0.5 points on the EDSS or 2 points in one of the EDSS functional system scores, or at least 1 point in two or more of the EDSS functional system scores. Confirmed disability progression is defined as an increase in the EDSS score compared to EDSS at month 3 which is of at least 1 point (or 0.5 points if the baseline EDSS >5.5) and is sustained for three months (measured at month 12 and confirmed at month 15 or measured at month 24 and confirmed at month 27 or measured at a relapse evaluation prior to or at month 24 and confirmed at the next visit or the latest at month 27).

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

Secondary outcomes (25)
  1. Annualized relapse rate evaluated at month 27

    Defined as the total number of confirmed relapses experienced during the intervention for each patient divided by years of exposure to the intervention and excluding the first three months for both outcome and exposure.

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

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

    New or enlarged brain lesions are evaluated at month 15 and compared to month 3 and at month 27 and compared to month 15; results from unscheduled MRIs between month 3 and month 27 are also considered.

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

  3. Serum neurofilament light chain (sNfL)

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

  4. Percentage of patients with disability improvement confirmed at 3 months

    Confirmed disability improvement is defined as a reduction in EDSS (expanded disability status scale) score compared to EDSS at month 3 which is of at least 1 point (or 0.5 points if the baseline EDSS >5.5). The EDSS score ranges from 0 to 10 with 0 indicating no neurological disability and 10 indicating death from MS. Measured at month 12 and confirmed at month 15 or measured at month 24 and confirmed at month 27.

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

  5. The time to onset of disability worsening confirmed at 3 months

    Confirmed disability worsening is defined as an increase in the EDSS (expanded disability status scale) score compared to EDSS at month 3 which is of at least 1 point (or 0.5 points if the baseline EDSS >5.5). The EDSS score ranges from 0 to 10 with 0 indicating no neurological disability and 10 indicating death from MS. Measured at month 12 and confirmed at month 15 or measured at month 24 and confirmed at month 27 or measured at a relapse evaluation prior to or at month 24 and confirmed at the next visit or the latest at month 27.

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

  6. Cumulative change in EDSS score

    Calculated as area under the curve (AUC) for measured values of the EDSS (expanded disability status scale) score from month 3 to month 24. The EDSS score ranges from 0 to 10 with 0 indicating no neurological disability and 10 indicating death from MS.

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

  7. Multiple Sclerosis Functional Composite (MSFC)

    A composite score used to assess neurological function by combining results from the Timed 25-Foot Walk (T25FW) test, the Nine-Hole Peg Test (9HPT) and the Symbol Digit Modalities Test (SDMT) evaluated at months 0, 12 and 24.

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

  8. Symbol Digit Modalities Test (SDMT)

    A measure of cognitive function and especially processing speed - evaluated at months 0, 12 and 24.

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

  9. California Verbal Learning Test-II (CVLT-II)

    A measure of verbal learning and memory - evaluated at months 0, 12 and 24.

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

  10. Brief Visuospatial Memory Test - Revised (BVMR-R)

    A measure of visuospatial memory - evaluated at months 0, 12 and 24.

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

  11. Intra-eye change in peripapillary retinal nerve fiber layer (RNFL) thickness

    Measured using Optical Coherence Tomography (OCT) at months 0, 12 and 24.

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

  12. Intra-eye change in ganglion cell and inner plexiform layer (GCIPL) thickness

    Measured using Optical Coherence Tomography (OCT) at months 0, 12 and 24.

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

  13. Modified Fatigue Impact Scale (MFIS-21)

    The MFIS-21 consists of a physical subscale (ranges from 0-36), a cognitive subscale (ranges from 0-40) and a psychosocial subscale (ranges from 0-8). The total MFIS-21 scale is computed by adding the scores from the physical, the cognitive and the psychosocial subscales. It ranges from 0-84 with higher scores indicating a greater impact from fatigue. MFIS-21 is evaluated longitudinally at months 0, 3, 6, 9, 12, 15, 18, 21, 24 and 27.

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

  14. Multiple Sclerosis Quality of Life-54 (MSQOL-54)

    The MSQOL-54 questionnaire is used to calculate a physical health composite score and a mental health composite score. They both range from 0-100 with higher scores indicating better health/ higher quality of life. The questionnaire is administered at months 0, 12 and 24.

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

  15. Brain-derived neurotrophic factor (BDNF)

    Brain-derived neurotrophic factor measured in platelet-free plasma samples using ELISA or mesoscale. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  16. C-reactive protein (CRP)

    CRP measured in plasma (mg/L) as a biomarker of infection and systemic inflammation. Lower-limit of quantification: 0,4 mg/L. Values below 0,4 mg/L are imputed as 0,2 mg/L. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  17. Triglycerides

    Plasma triglycerides (mmol/l) monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  18. Non-HDL cholesterol

    Non-HDL cholesterol calculated as total cholesterol minus HDL cholesterol (mmol/l). Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  19. C-peptide

    Proinsulin C-peptide (pmol/l) measured in plasma. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  20. Fasting glucose

    Plasma glucose (mmol/l). Participants abstain from eating and drinking after 22.00 the day before. Only water is allowed. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  21. 8-iso-prostaglandin F2α and other F2-isoprostanes

    F2-isoprostanes with a specific focus on 8-iso-prostaglandin F2α measured in morningurine or blood samples as a marker of oxidative stress-related lipid oxidation. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  22. 8-oxo-dG

    8-oxo-dG (8-Oxo-2'-deoxyguanosine) measured in blood or morningurine samples as a marker of oxidative stress-related DNA damage. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  23. Fecal lipocalin

    Lipocalin measured in fecal samples as a sensitive biomarker of intestinal inflammation. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  24. Microbiota profiling of fecal samples

    Microbiota profiling of fecal samples using molecular biology methods including but not limited to sequencing and flowcytometric analyses. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

  25. Serum and fecal metabolomics

    Targetted and untargetted liquid-chromatography mass-spectrometry-based metabolomics to measure diet-, host- and microbial-derived metabolites. Targetted analyses aim to quantify indole-3-propionic acid and its metabolites (biomarker of compliance as well as absorptive and metabolic capacity), other bacterial- and host metabolites of tryptophan as well as short-chain fatty acids. Monitored longitudinally at months 0, 3, 15 and 27.

    Measured: The time between month 0 and month 27 after initiation of supplementation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2026
  2. Study start26 Jan 2026
  3. Primary completion15 Jul 2028 (estimated)
  4. Study completion15 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07318129
Sponsor's protocol ID
H-25042489
Acronym
iPROACT-MS
Status last verified
Dec 2025
First submitted
23 Nov 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in published articles, after deidentification (text, tables, figures, and appendices).

Questions about this trial

What is this clinical trial studying?

A study testing Indole-3-propionic acid (IPA) in people with Relapsing Remitting Multiple Sclerosis (RRMS), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jette Lautrup Frederiksen, MD, dr.med, professor (+4538633041, jette.lautrup.battistini@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

No evidence of disease activity (NEDA) (time frame: The time between month 3 and month 27 after initiation of supplementation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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