Indole-3-PROpionic Acid Clinical Trials

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-27

Study Completion Date

2028-07-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Relapsing Remitting Multiple Sclerosis (RRMS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Each set of capsule containers (the containers to be used by a study participant during the intervention) is labelled with a unique ID and no other identifier. A randomization key is prepared by an external party randomizing study participants to IPA or placebo using stratified block randomization with random block sizes of 4 or 6. Stratification accounts for recent evidence of disease activity (yes vs. no) defined as experience of clinical relapses within the past year or demonstration of new, contrast-enhanced or enlarged lesions on a clinical MRI scan performed within the last 12 months from randomization.

A software system is used to reveal the unique container ID to be used by each randomized participant without revealing its corresponding arm. Only after all study participants have completed the trial and the collected data have been cleaned and quality checked, are the researchers performing the statistical analyses informed about which participants belong to each arm.

Study Groups

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Placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_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)

IPA capsules

Group Type EXPERIMENTAL

Indole-3-propionic acid (IPA)

Intervention Type 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.

Interventions

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Placebo

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

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No