HFP (High-Fiber Supplement) in MS (Multiple Sclerosis)

Status Enrolling by invitation

Clinical Trial Summary

It has been suggested that dysbiosis of gut commensal bacteria increases the risk of autoimmune diseases including MS. However, there is no viable intervention available to correct dysbiosis. Since high-fiber supplement can promote the growth of healthy bacteria in the gut, the investigators propose to examine the effect of specially designed high-fiber supplement on the growth of short-chain fatty acid-producing gut bacteria and development of regulatory immune cells. Although dysbiosis is an alteration of microbial composition, enteric bacteria involved in gut dysbiosis of MS are different in ethnic groups due to difference in genetics, diet, and environmental exposures. Therefore, it is important to determine the intestinal bacterial composition involved in the MS dysbiosis in each ethnicity and geographical location. Additionally, it is necessary to find a non-invasive biomarker for gut dysbiosis-mediated CNS autoimmunity in MS. Since the investigators found that fecal Lipocalin 2 (Lcn-2) is a biomarker of gut dysbiosis-mediated CNS autoimmunity in MS animal models, the investigators will examine the association of fecal Lcn-2 levels with disease activation in MS.

Clinical Trial Description

Our collaborator, Dr. Liping Zhao, developed a high fiber supplement (HFS), NBT-NM108. His recent study suggests an association between intake of NBT-NM108 and reduced gut dysbiosis and increased abundance of short chain fatty acid (SCFA)-producing gut bacteria. Since reports suggest that Relapsing Remitting Multiple Sclerosis (RRMS) may be associated with gut dysbiosis and decreased production of SCFAs, we will investigate the effect of NBT-NM108 on RRMS-associated gut dysbiosis. 50 RRMS patients will be enrolled. The first group (Group A) of RRMS patients (n=25) will receive NBT-NM108 for 12 weeks (High-fiber supplement group). The second group of RRMS patients (Group B) (n=25) will not consume any high fiber supplement. We will investigate the effect of NBT-NM108 on gut microbiota and immune parameters involved in MS. We will also investigate the association between intestinal inflammation and relapse. The blood and fecal samples will be collected at the time of relapse and remission, and fecal Lipocalin 2 levels, an intestinal inflammation biomarker, will be examined. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04574024
Study type	Interventional
Source	Rutgers, The State University of New Jersey
Contact
Status	Enrolling by invitation
Phase	Phase 1/Phase 2
Start date	March 21, 2022
Completion date	September 30, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.