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

Multiple Sclerosis Clinical Trial

Official title:

Effect of High-fiber Supplement in Multiple Sclerosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04574024
• Other study ID #: Pro2019001677
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: March 21, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients with first demyelinating event who meet the McDonald criteria for definite MS or established relapsing remitting MS patients.

2. We will recruit Caucasian due to reports suggesting higher incidence of MS in Caucasian. Also, western diet which is common among Caucasian can promote MS.

3. MS patients treated with either Glatiramer acetate or Fingolimod for at least 6 months prior to enrollment.

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• NBT-NM108 (60 g/day)
Patients will receive NBT-NM108 at 60 g/day.

Other:
• NBT-NM108 (0 g/day)
Patients will receive NBT-NM108 at 0 g/day.

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Suhayl Dhib-Jalbut, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of high-fiber supplement (HFS) on (1) composition of gut microbiota and (2)production of short-chain fatty acids (SCFAs) and Foxp3 regulatory T cells (Tregs).	(1) The fecal sample will be collected from MS patients with/without high-fiber supplement (HFS) and composition of gut microbiota will be examined. (2) The blood cells will be isolated from MS patients with/without HFS-treatment and production of SCFAs such as acetate, propionate, and butyrate, and development of Foxp3 Tregs will be examined.	Change from baseline to day183
Primary	Examine fecal Lcn-2 levels before/after MS relapse	Fecal Lcn-2 levels will be examined in MS patients with remission and relapse	From date of randomization until the date of first documented progression, assessed up to 36 months