Indole-3-PROpionic Acid Clinical Trials - Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGlostrup University Hospital, Copenhagen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Active malignancy
Diagnosis of Crohn's disease and ulcerative colitis
Other comorbidities deemed to be relevant
Haematopoietic stem cell transplantation
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Dietary supplementTwo 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 supplementTwo 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Indole-3-propionic acid (IPA)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
The time between month 3 and month 27 after initiation of supplementation.Secondary outcomes
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.
Time frame
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.
Time frame
The time between month 3 and month 27 after initiation of supplementation.3
Serum neurofilament light chain (sNfL)
Time frame
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.
Time frame
The time between month 3 and month 27 after initiation of supplementation.Other outcomes
1
Percentage of patients with progression independent of relapse and/or MRI activity
Tertiary efficacy outcome related to multiple sclerosis. Progression is defined as an increase in the EDSS score compared to the 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.
Time frame
The time between month 3 and month 24 after initiation of supplementation.2
Six Spot Step Test (SSST)
Tertiary efficacy outcome related to multiple sclerosis. A measure of walking ability, including speed, co-ordination and balance - evaluated at month 0, month 12 and month 24.
Time frame
The time between month 0 and month 24 after initiation of supplementation.3
Nine-Hole Peg Test (9-HPT)
Tertiary efficacy outcome related to multiple sclerosis. A measure of finger dexterity - evaluated at months 0, 12 and 24.
Time frame
The time between month 0 and month 24 after initiation of supplementation.4
Glial Fibrillary Acidic Protein (GFAP)
Tertiary efficacy outcome related to multiple sclerosis. Monitored longitudinally in serum samples at months 0, 3, 15 and 27.
Time frame
The time between month 0 and month 27 after initiation of supplementation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Glostrup University Hospital, Copenhagen
Lead sponsor
University of Copenhagen
Collaborator
University of Southampton
Collaborator
Source ClinicalTrials.gov