Effect of High-fiber Supplement in Multiple Sclerosis
NBT-NM108
Autoimmune Diseases+4
+ Demyelinating Diseases
+ Immune System Diseases
Basic Science Study
Summary
Study start date: March 21, 2022
Actual date on which the first participant was enrolled.Our collaborator, Dr. Liping Zhao, developed a high-fiber supplement (HFS), NBT-NM108. His recent study has suggested an association between intake of NBT-NM108 and increased abundance of short-chain fatty acid (SCFA)-producing gut bacteria. Recent studies have suggested that Relapsing-Remitting Multiple Sclerosis (RRMS) is associated with gut dysbiosis, alteration of gut bacteria, and decreased production of SCFAs. Therefore, we have investigated the effect of NBT-NM108 on RRMS-associated gut dysbiosis and the cytokines produced by immune cells. Seven patients were enrolled, and their stool samples were collected before the treatment with NBT-NM108 (Baseline). Three patients from the enrolled patients consumed NBT-NM108 three times a day at 60 g/day for 8 weeks. Two patients further consumed NBT-NM108 for four more weeks (a total of 12 weeks). Stool and blood samples were collected at 3 time points (baseline, 8 weeks post-NBT-NM108, and 12 weeks post-NBT-NM108). We have investigated the effect of NBT-NM108 on gut microbiota and immune parameters involved in MS.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Patients with the first demyelinating event who meet the McDonald criteria for relapsing remitting MS. Exclusion Criteria: 1. Primary or secondary progressive MS. 2. Patients with autoimmune comorbidities. 3. Having received prior chemotherapy. 4. Having received Dimethylfumarate (DMF). 5. Pregnant women. 6. Cognitively impaired. 7. Antibiotic use within last 6 months. 8. Probiotic use within 2 months. 9. Self-reported allergy or intolerance to any ingredients in the fiber supplement. 10. Self-reported or diagnosed gastrointestinal symptoms, disorders or adenomas. 11. Active or history of malignant tumors.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert Wood Johnson University Hospital
New Brunswick, United StatesOpen Robert Wood Johnson University Hospital in Google Maps