Synbiotic Supplementation as a Part of Dietary Modification in Multipl
The Effects of Synbiotic Supplementation as Part of Dietary Modification on Multiple Sclerosis-related Parameters and Quality of Life in Patients With Multiple Sclerosis: a Single Blind Randomised Controlled Clinical Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- MNT+Synbiotic
Placebo
- MNT+Placebo
What it measured
Main measures
The quality of life in patients with multiple sclerosis
From enrollment (at week 1) to the middle (at week 6) and end (at week 12) of intervention.
Quality of life (reported by participants)The Expanded Disability Status Scale Score
From enrollment (at week 1) to the middle (at week 6) and end (at week 12) of intervention.
Disability progression
Other measures (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
Arm and hand functionPhysical functionBody Mass Index
Baseline (Week 1), Week 6, and Week 12
Fasting Blood Glucose
Baseline (Week 1), Week 6, and Week 12
Fasting Insulin
Baseline (Week 1), Week 6, and Week 12
Total Cholesterol
Baseline (Week 1), Week 6, and Week 12
Low-Density Lipoprotein Cholesterol
Baseline (Week 1), Week 6, and Week 12
Who could take part
Relapsing MS · 19 to 64
Show the full criteria
Inclusion criteria
* 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)
Exclusion criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2020
Main results due
Nov 2021
Finished
Nov 2023