NCT04574024CompletedPhase 1/2
HFS (High-Fiber Supplement) in MS (Multiple Sclerosis)
Effect of High-fiber Supplement in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 17 Dec 2024
Brief summary (registry, in English)
Multiple sclerosis (MS) is an autoimmune disease directed against the Central Nervous System (CNS). Recent studies have indicated that changes in the gut microbiota are associated with disease initiation and progression. The reduction of bacterial taxa involved in producing health-promoting metabolites, such as short-chain fatty acids (SCFAs), has been reported in MS patients. SCFAs play an important role in the suppression of inflammation. The levels of SCFAs in the blood of MS patients are significantly reduced when compared to those of healthy controls. Since the intake of dietary fiber increases the growth of SCFA-producing bacteria, we investigated the effect of a high-fiber supplement (HFS) on gut bacteria and immunological parameters in MS patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 21 Sept 2020
- Start date
- 21 Mar 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Suhayl Dhib-Jalbut, MD
- Diseases
- Multiple sclerosis
- NCT number
- NCT04574024
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 7
- From 21 Mar 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received prior chemotherapy.
- Having received Dimethylfumarate (DMF).
Other illness
- Patients with autoimmune comorbidities.
- Self-reported allergy or intolerance to any ingredients in the fiber supplement.
- Self-reported or diagnosed gastrointestinal symptoms, disorders or adenomas.
- Active or history of malignant tumors.
Other
- Primary or secondary progressive MS.
- Pregnant women.
- Cognitively impaired.
- Antibiotic use within last 6 months.
- Probiotic use within 2 months.
Who the study is looking for
- Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS.
Age in the registry: 21 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.