Synbiotic Supplementation as a Part of Dietary Modification in Multiple Sclerosis

NCT07789171 | Completed

• 1 other identifier: 18-AKD-153
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multiple Sclerosis; Nutritional Status; Medical Nutrition Therapy; synbiotics; Life Quality

Outcome Measures

Primary Outcomes (2)

• The quality of life in patients with multiple sclerosis

  The Multiple Sclerosis Quality of Life-54 (MSQOL-54) consists of two composite scores, the Physical Health Composite (PHC) and the Mental Health Composite (MHC), 13 subscales, and 2 single-item measures. The subscale and composite scores range from 0 to 100, with higher scores indicating better health-related quality of life.

  From enrollment (at week 1) to the middle (at week 6) and end (at week 12) of intervention.

• The Expanded Disability Status Scale Score

  Disability was assessed using the Expanded Disability Status Scale (EDSS). The EDSS is an ordinal scale ranging from 0 to 10 in 0.5-point increments, where 0 indicates a normal neurological examination and 10 represents death due to multiple sclerosis. Higher EDSS scores indicate greater neurological disability.

  From enrollment (at week 1) to the middle (at week 6) and end (at week 12) of intervention.

Secondary Outcomes (19)

• body weight

  From enrollment (at week 1) to the middle (at week 6) and end (at week 12) of intervention.

• Waist Circumference

  Baseline (Week 1), Week 6, and Week 12

• Mid-Upper Arm Circumference

  Baseline (Week 1), Week 6, and Week 12

• Triceps Skinfold Thickness

  Baseline (Week 1), Week 6, and Week 12

• Handgrip Strength

  Baseline (Week 1), Week 6, and Week 12

Study Arms (2)

Control Group

PLACEBO COMPARATOR

This group included participants aged 19-64 years who were diagnosed with RRMS and monitored at the MS outpatient clinic of Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital. The number of participants in the control group was 20.

Dietary Supplement: MNT+Placebo

Study Group

ACTIVE COMPARATOR

This group included participants aged 19-64 years who were diagnosed with RRMS and monitored at the MS outpatient clinic of Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital. The number of participants in the control group was 18.

Dietary Supplement: MNT+Synbiotic

Interventions

MNT+Placebo DIETARY_SUPPLEMENT

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.

Control Group

MNT+Synbiotic DIETARY_SUPPLEMENT

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.

Study Group

Eligibility Criteria

• Age: 19 Years - 64 Years
• Gender Eligibility Details: Females are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being aged 19-64 years
• Having an EDSS score of 6.5 or below,
• Being clinically diagnosed with RRMS and being under the care of the relevant outpatient clinic,
• Having had no attacks in the last month,
• Not receiving immunosuppressive drug therapy (Cyclophosphamide, Methotrexate, Azathioprine, Mitoxantrone, Mycophenolate Mofetil)
• Not being deficient in vitamin D
• Being a female diagnosed at least one year ago (to ensure a homogeneous gender distribution in the group and because the incidence of MS is higher in females)

You may not qualify if:

• Individuals who have used probiotics/synbiotics or antibiotics within the last two weeks prior to participating in the study, either on a doctor's advice or of their own accord, and who will be required to use probiotics/synbiotics or antibiotics during the study period.
• Individuals with enteric inflammation, advanced liver or kidney disease,
• Individuals diagnosed by a physician with diabetes, hyperlipidemia, gout, chronic renal failure, or liver disease requiring special medical nutrition therapy,
• Pregnant or lactating women,
• Individuals with a body mass index of 30 kg/m2 or above,
• Individuals who have participated in another clinical trial within the last month,
• Individuals who have previously reported sensitivity to probiotic/synbiotic treatment,
• Individuals whose standard medical treatment or medication dosage is changed or planned to change during the study period,
• Individuals who cannot ensure continuity in research follow-up

Sponsors & Collaborators

• Hacettepe University: lead
• Bakırkoy Prof Dr Mazhar Osman Mental Health and Neurological Diseases Hospital: collaborator

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: August 27, 2026
• Study Start: March 1, 2020
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2023
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)