NCT07789171Befejeződött
Synbiotic Supplementation as a Part of Dietary Modification in Multiple Sclerosis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 27.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 38 (tényleges)
- Első benyújtás
- 2026. márc. 14.
- Kezdés
- 2020. márc. 1.
- Elsődleges befejezés
- 2021. nov. 29.
- Fő szponzor
- Hacettepe University
- Betegségek
- Sclerosis multiplex (SM)
- NCT-szám
- NCT07789171
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 38
- 2020. márc. 1. és az elsődleges befejezés (2021. nov. 29.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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 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,
Más betegség
- 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,
Egyéb
- 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 cannot ensure continuity in research follow-up
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 19 év – 64 év · Nem: csak nők · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Hacettepe University | Ankara | Törökország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.