Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease

NCT07038226 | Completed DMC

• 2 other identifiers: KHUH 2023-03-002-0082022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to assess the impact of fecal microbiota transplantation (FMT) delivered via oral capsules in patients with Parkinson's disease who suffer from refractory constipation. The primary questions this trial seeks to answer are: Does FMT delivered through oral capsules improve constipation? Does FMT delivered through oral capsules enhance the motor symptoms associated with Parkinson's disease? Is FMT delivered through oral capsules safe for individuals with Parkinson's disease? Researchers will compare the intervention group with a control group to determine the presence of a placebo effect. Participants in the study will: Take antibiotics as a pre-treatment regimen for 5 days, followed by oral capsules containing either fecal microbiota or a placebo for 14 days. Attend clinic visits at screening, visit 1 (baseline), visit 2 (4 weeks), and visit 3 (12 weeks). Collect fecal samples and maintain a 2-week diary of their bowel habits before visits 1, 2, and 3.

Conditions

Parkinson Disease; Constipation

Keywords

fecal transplantation; oral capsule

Outcome Measures

Primary Outcomes (2)

• Change from baseline in 39-Item Parkinson's Disease Questionnaire

  The minimum score is 0 and the maximum score is 100, with higher scores indicating worse quality of life.

  Baseline up to Week 12

• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Any adverse effects derived from the intervention

  up to 12 weeks

Secondary Outcomes (4)

• Change from baseline in Wexner Constipation Score

  Baseline up to Week 12

• Change from baseline in Bristol stool scale

  Baseline up to Week 12

• Change from baseline in Geriatric Depression Scale-15 (short version)

  Baseline up to Week 12

• Change from baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with Hoehn and Yahr Stage (HYS)

  Baseline up to Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive a visually identical capsule containing skim milk powder.

Biological: Placebo

Oral capsule-delivered FMT

EXPERIMENTAL

Participants will receive oral capsules of lysophilized fecal microbiota.

Biological: Oral capsule-delivered FMT

Interventions

Placebo BIOLOGICAL

a visually identical capsule containing skim milk powder

Placebo

Oral capsule-delivered FMT BIOLOGICAL

Oral capsules of lysophilized fecal microbiota

Oral capsule-delivered FMT

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 40 and 80 years.
• Voluntarily signed the informed consent form for participation in this study.
• Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria.
• Either do not have or have controlled Parkinson's disease motor complications, allowing for stable use of anti-Parkinson's medication during the study period (12 weeks).
• Meet the definition of refractory constipation as follows:
• A. On at least 1 out of 4 bowel movements, two or more of the following apply: i. Excessive straining.
• ii. Lumpy/hard stools (Bristol Stool Form Scale 1-2). iii. Sensation of incomplete evacuation after defecation. iv. Sensation of anorectal obstruction or blockage. v. Manual maneuvers to facilitate defecation. vi. Fewer than three spontaneous bowel movements per week. B. Rarely experience loose stools without the use of laxatives. C. Symptoms began at least 6 months prior to diagnosis and have persisted for the past 3 months.
• D. Constipation shows no improvement despite the use of various types of laxatives (bulk-forming, osmotic, saline, stimulant, or others) individually or in combination for at least 4 weeks.

You may not qualify if:

• Individuals with cognitive impairment scoring less than 20 on the Korean version of the Mini-Mental State Examination (K-MMSE).
• Individuals who have contraindications for fecal microbiota transplantation (acute infections, immunocompromised status, or a history of food allergies).
• Individuals with ileus or colonic pseudo-obstruction.
• Individuals with a history of major gastrointestinal surgeries, such as resection.
• Individuals with suspected or confirmed gastrointestinal obstruction or gastric outlet obstruction.
• Individuals with suspected or confirmed active gastrointestinal bleeding.
• Individuals with gastrointestinal diseases requiring treatment or medical consultation.
• Individuals receiving parenteral nutrition or enteral feeding.
• Individuals experiencing dysphagia symptoms (difficulty swallowing, choking during meals, etc.).
• Individuals who have taken antibiotics within 3 months prior to screening.
• Individuals who have participated in other drug clinical trials within 3 months prior to screening.
• Pregnant individuals.
• Individuals with other severe diseases that may impair quality of life or the ability to perform daily activities.
• Individuals with contraindications to the use of antibiotics (Ciprofloxacin, Metronidazole) as referenced in the text.
• Any other case where the researcher deems participation in the clinical trial to be inappropriate for the subject.

Sponsors & Collaborators

• Kyung Hee University Hospital: lead
• Kyungpook National University Hospital: collaborator

Study Sites (1)

Kyung Hee University Hospital

Seoul, 02447, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Block randomization is performed by an unblinded Clinical Research Associate (CRA), assigning participants to either the treatment group or the placebo group in a 1:1 ratio. All other researchers involved in the study remain blinded to group assignments. The researcher responsible for randomization does not engage in any other aspects of the research process. Randomization records are maintained separately from other clinical data to ensure confidentiality. Researchers, aside from the one handling randomization, are unaware of which participants are in the treatment or placebo group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 26, 2025
• Study Start: October 2, 2023
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

KR (1)