Synbiotic Supplementation as a Part of Dietary Modification in Multiple Sclerosis

NCT07789171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-08-27

No results posted yet for this study

Summary

Multiple Sclerosis (MS) is a chronic inflammatory and demyelinating disease of the central nervous system, influenced by genetic, epigenetic, and immunological factors, as well as environmental factors such as nutrition. Medical nutrition therapy (MNT) has the potential to improve the quality of life for individuals with MS and enhance the disease course, particularly by reducing inflammation, providing neural protection, and regulating metabolic factors such as body weight. Recently, probiotic/synbiotic-supported studies have been conducted to investigate the effects of gut microbiota on the disease; however, only a few studies have thoroughly evaluated detailed dietary patterns. This study aims to examine the effects of the Mediterranean Diet, which is thought to have an impact on MS patients and many autoimmune diseases, along with synbiotic use, on the disease and quality of life of MS patients.

All patients were given MNT during the study period. At the 6th week, the study group received probiotics while the control group received placebo twice a day as recommended. In the 1st (W1), 6th (W6) and 12th (W12) weeks, three- day food consumption and 24-hour physical activity records, anthropometric measurements, hand grip strength and biochemical indicators, Healthy Eating Index-2015 (HEI-2015), Beck Depression Inventory (BDI), Mediterranean Diet Adherence Scale (MEDAS), Multiple Sclerosis Quality of Life Scale-54 (MSQoL-54), Expanded Disability Status Scale (EDSS) scores were evaluated.

Conditions

  • Multiple Sclerosis (MS) - Relapsing-remitting

Interventions

DIETARY_SUPPLEMENT

MNT+Placebo

The participants in this group received only MNT during the first 6-week period, and MNT+placebo supplementation (2 tablets a day) during the second 6-week period. The total intervention period was 12 weeks. The placebo product contained only vitamin C and starch. The number of participants in the control group was 20.

DIETARY_SUPPLEMENT

MNT+Synbiotic

The participants in this group received only MNT during the first 6-week period, and MNT+synbiotic supplementation (2 tablets a day) during the second 6-week period. The total intervention period was 12 weeks. The synbiotic product contained Lactobacillus plantarum, Streptococcus thermophilus, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium longum Enterococcus faecium, fructo-oligosaccharide, microcrystalline cellulose, corn starch, vitamin C, sweetener (xylitol and isomalt), milk flavor, anti-caking agent (hydroxypropyl methylcellulose), vanilla flavoring, anti-caking agent (magnesium salts of fatty acids). The number of participants in the control group was 18.

Sponsors & Collaborators

  • Bakırkoy Prof Dr Mazhar Osman Mental Health and Neurological Diseases Hospital

    collaborator UNKNOWN
  • Hacettepe University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2021-11-29
Completion
2023-11-29

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07789171 on ClinicalTrials.gov