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Efficacy of active probiotics in the treatment of constipation in patients with Parkinson's disease

Efficacy of active probiotics in the treatment of constipation in patients with Parkinson's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066482
Enrollment
Unknown
Registered
2022-12-06
Start date
2017-12-01
Completion date
Unknown
Last updated
2023-05-15

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:BIFICO 2 capsules tid,Bacillus Licheniformis 2 capsule tid
Control group:Keep the original anti Parkinson's drugs

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Be of any age or gender. 2) Meet the diagnostic criteria for Parkinson's disease. 3) Meet the diagnostic criteria of chronic constipation. 1. Symptoms must include 2 or more of the following: (1) at least 25% of bowel movements are strained; (2) at least 25% of bowel movements are dry bulbous or hard; (3) at least 25% of bowel movements are incomplete; (4) at least 25% of bowel movements have anorectal obstruction or blockage; (5) at least 25% of bowel movements require manual assistance (e.g., finger-assisted bowel movements, pelvic floor support); (6) The number of bowel movements is less than 3 times/week. 2. There are few loose stools without the use of laxatives. 3. There is insufficient evidence to diagnose irritable bowel syndrome. Symptoms have been present for at least 6 months prior to diagnosis, and the symptoms in the last 3 months meet the above criteria. 4) Understand the purpose and procedures of the trial and voluntarily participate in the trial, are willing to comply with the contraindications and restrictions specified in the protocol, are able to complete the log and questionnaire as required, and agree to sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1: Severe cardiovascular disease, neurological or psychiatric disease or other reasons for inability to cooperate with the study, cancer or AIDS. 2: Patients with localized intestinal lesions, intestinal obstruction, toxic megacolon, gastrointestinal tumors and other organic intestinal lesions. 3: Patients with known allergy or hypersensitivity to the test drug or excipients.

Design outcomes

Primary

MeasureTime frame
Patient assessment of constipation symptom;

Secondary

MeasureTime frame
Unified Parkinson Disease Rating Scale (UPDRS);Constipation Scale;mini-mental state examination;Hamilton Anxiety Scale;Hamilton Depression Scale;Epworth sleepiness score;Hoehn-Yahr;Colon transit time;RBD Questionnaire–Hong Kong;

Countries

China

Contacts

Public ContactHouzhen Tuo

Beijing Friendship Hospital, Capital Medical University

tuohouzhen@ccmu.edu.cn+86 13683628005

Outcome results

None listed

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