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The effect of synbiotic supplementation on Parkinson's disease

Evaluation of the effect of synbiotic supplementation on antioxidant and inflammatory markers, serum zonulin level and quality of life in patients with Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180818040827N2
Enrollment
80
Registered
2021-03-16
Start date
2021-04-12
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease. Parkinson's disease

Interventions

Intervention 1: Intervention group: They will receive 5 g/d of synbiotic supplement, Containing Lactobacillus, Bifidobacterium and Streptococcus species and Inulin prebiotic( product of Tak gen zist

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients who agree to participate in the study Diagnosis of Parkinson's by a neurologist based on the diagnostic criteria of the Parkinson's Disease Association (UK Parkinson's disease society Brain Bank criteria) Age 50 to 80 years

Exclusion criteria

Exclusion criteria: Regular consumption of products fortified with probiotics and prebiotics, probiotic and prebiotics supplements at least 2 months before start of the study Take antibiotics or laxatives at least 2 months before the start of the study Take antioxidant supplements or supplements that affect the disease Having a history of gastrointestinal surgery History of chronic gastrointestinal disease, hypothyroidism or hyperthyroidism, severe psychosis, or other concomitant neurological diseases, cognitive impairment, smoking or nicotine or alcohol use Having a history of type 1 and 2 diabetes Taking anti-inflammatory and immunosuppressive drugs Sensitivity to the compounds in the supplement Having hoehn and yahr score of 5 out of 5

Design outcomes

Primary

MeasureTime frame
Symptome of Parkinson's disease (Motor and non motor). Timepoint: At baseline and after 12 weeks. Method of measurement: Using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire and Calculate the score of the questions and use of them.;Zonulin. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;High sensitive C-reactive protein (Hs-CRP). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;TNF-a. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Malodialdehyde. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Glutathione. Timepoint: At baseline and after 12 weeks. Method of measurement: biochemical kit of KiaZist Co.;Disease stage progression. Timepoint: At baseline and after 12 weeks. Method of measurement: Hoehn and yahr scale.;Lipopolysaccharid (endotoxin). Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.

Secondary

MeasureTime frame
Quality of life. Timepoint: at baseline and after 12 week. Method of measurement: Parkinson's Disease Questionnaire - 39.;Dietary intake. Timepoint: at baseline, Week six and twelve. Method of measurement: food record.;Depression and anxiety. Timepoint: At baseline and after 12 weeks. Method of measurement: beck depression questionnaire and hospital anxiety and depression scale.;Fatigue. Timepoint: At baseline and after 12 weeks. Method of measurement: Fatigue severity scale questionnaire.;Body mass index. Timepoint: At baseline and after 12 weeks. Method of measurement: It will calculated by weight divided by height (in meters).;Weight. Timepoint: At baseline and after 12 weeks. Method of measurement: Standard weight scale.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactsanaz mehrabani

Esfahan University of Medical Sciences

sanaz_mehr6500@yahoo.com+98 31 3668 1378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026