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Clinical efficacy evaluation of probiotics in patients with Parkinson's disease

Clinical efficacy evaluation of probiotics in patients with Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077412
Enrollment
Unknown
Registered
2023-11-08
Start date
2022-08-27
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Parkinson's disease

Interventions

Probiotics group :Lactobacillus plantarum CCFM405
Placebo group:Probiotic products without CCFM405

Sponsors

Yancheng Tinghu District People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients meeting the following criteria are eligible to participate in the study ? PD was clinically diagnosed by MDS (International Dyspraxia Association) in 2015; ? Constipation in accordance with the Roman ? criteria must include two or more of the following symptoms: at least 25% of the constipation experience difficulty; At least 25% of bowel movements are lumpy or stiff; At least 25% of bowel movements have a lack of bowel movement; Anorectal obstruction in at least 25% of defecation; At least 25% of defecation requires manual assistance (finger picking, pelvic floor support); Defecation less than 3 times a week; ? 18-75 years old, male and female; ? No serious cognitive dysfunction affecting written and spoken expression; ? No serious aphasia or hearing impairment; ? The patient fills out a written informed consent form, basic information questionnaire, dietary structure and living condition questionnaire, and promises to cooperate with the research throughout the entire experimental period.

Exclusion criteria

Exclusion criteria: Patients who met one of the following exclusion criteria were excluded from the study. ? Serious cognitive dysfunction affecting written and spoken expression; ? severe aphasia or dysarthria; ? Suffering from mental illness and unable to carry out relevant examinations as required; ? other serious physical diseases or severe abnormalities of liver and kidney function; ? Patients who have received surgical treatment for PD; ? Patients who need to take immunosuppressants for a long time or take antibiotics within 1 month before enrollment and take antibiotics during follow-up; ? During the follow-up period, patients took defecation promoting drugs, such as polyethylene glycol electrolyte, phenolphthalein tablets, senna leaf, etc.; ? suffering from chronic digestive system diseases or tumors, such as digestive tract ulcers, inflammatory enteritis, serious liver disease patients; ? Patients with irregular eating habits and great changes during the follow-up; ? Patients with chronic digestive diseases or tumors, such as digestive tract ulcers, inflammatory enteritis, and severe liver disease. ? Persons who are allergic to the test sample or have obvious digestive tract symptoms that they cannot tolerate.

Design outcomes

Primary

MeasureTime frame
Motor symptoms and non-motor symptoms;Depression;Anxiety;Sleep;Constipation quality of life;39 item Parkinson’s Disease Questionnaire;Hoehn and Yahr stage;The number of bowel movements;The Bristol Stool Form Scale;

Secondary

MeasureTime frame
Gut microbiota;Fecal metabolites;

Countries

China

Contacts

Public ContactSongli Zhang; Jianxin Zhao

Tinghu People's Hospital of Yancheng City; Jiangnan University

jxzhao@jiangnan.edu.cn+86 510 8591 2155

Outcome results

None listed

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