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

Glostrup University Hospital, Copenhagen

Status: Enrolling

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

Treatments: Dietary Supplement: Indole-3-propionic acid (IPA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07318129

H-25042489

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo capsules

Treatment:

Dietary Supplement: Placebo

Indole-3-propionic acid (IPA)

Experimental group

Description:

IPA capsules

Treatment:

Dietary Supplement: Indole-3-propionic acid (IPA)