Gut Microbiota and Tryptophan Metabolites in Parkinson's Disease
An Exploratory Case-Control Study of Fecal Microbiota and Targeted Tryptophan Metabolite Profiling in Patients With Parkinson's Disease
Parkinson's disease is a progressive neurological disorder that can also affect the digestive system. Changes in gut microorganisms and tryptophan metabolites may be associated with Parkinson's disease, but these relationships are not fully understood. This exploratory observational study will compare gut microbial communities and targeted tryptophan metabolite profiles between 15 participants with Parkinson's disease and 15 healthy controls matched by sex, age, and body mass index.
Each participant will provide clinical and lifestyle information and one stool sample. Stool samples will be analyzed using 16S ribosomal RNA gene sequencing and targeted liquid chromatography-tandem mass spectrometry. The study will evaluate differences in gut microbial composition and selected tryptophan metabolites and explore their associations with constipation, bowel habits, medication use, and clinical features of Parkinson's disease. No treatment will be assigned, and participants' usual medical care will not be changed. The findings are exploratory and are intended to guide larger future studies; they cannot establish causality or be used to diagnose Parkinson's disease.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: qinghan Guo
- 전화번호: 86+17753626689
- 이메일: ghqnxykd@163.com
연구 장소
-
-
Shandong
-
Laizhou, Shandong, 중국, 261400
- Laizhou People's Hospital
-
연락하다:
- Xiumei Gong
- 전화번호: +8618553631703
- 이메일: 18553631703@163.com
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Participants aged 45 to 90 years, of any sex. Participants able to understand the study, provide written informed consent, and provide an acceptable stool sample according to the study procedures.
For the Parkinson disease group: clinically established or clinically probable Parkinson disease diagnosed by a neurologist according to the Movement Disorder Society Clinical Diagnostic Criteria.
For the Parkinson disease group: preferably a disease duration of 5 years or less and Hoehn-Yahr stage I to III.
For the Parkinson disease group: stable antiparkinsonian medication regimen for at least 4 weeks before enrollment.
For the healthy control group: no history of Parkinson disease, parkinsonism, or another neurodegenerative disorder and no evident parkinsonian symptoms at screening.
Healthy controls matched individually to participants with Parkinson disease by sex, age within 5 years, and body mass index within 3 kg/m^2
Exclusion Criteria:
- Use of systemic antibiotics within 3 months before stool collection. Use of probiotics, prebiotics, tryptophan, 5-hydroxytryptophan, live biotherapeutic products, or other microbiome-related supplements within 4 weeks before stool collection.
Acute infection, fever, acute diarrhea, gastroenteritis, colonoscopy preparation, or a major dietary change within 4 weeks before stool collection.
Active inflammatory bowel disease, celiac disease, short-bowel syndrome, gastrointestinal malignancy, or major gastrointestinal surgery within 6 months.
Active cancer, decompensated liver or kidney disease, severe cardiovascular or hematological disease, active autoimmune disease, or current systemic glucocorticoid or immunosuppressive treatment.
Pregnancy or breastfeeding. Long-term exclusive enteral or parenteral nutrition. Inability to provide an acceptable stool sample or essential clinical information.
Any other condition considered by the investigator to compromise participant safety, study adherence, or interpretation of the results.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
|
Parkinson Disease Group
Participants aged 45 to 90 years with clinically established or clinically probable Parkinson disease.
Participants will provide clinical and lifestyle information and one stool sample for 16S ribosomal RNA gene sequencing and targeted tryptophan metabolite analysis.
No intervention will be assigned
|
Each participant will provide one stool sample.
Separate aliquots will be analyzed using 16S ribosomal RNA gene amplicon sequencing and targeted liquid chromatography-tandem mass spectrometry to characterize the gut microbiota and quantify prespecified tryptophan metabolites.
These analyses are conducted for research purposes only and will not be used for clinical diagnosis or treatment decisions.
|
|
Healthy Control Group
Healthy participants aged 45 to 90 years who are matched to the Parkinson disease group by sex, age, and body mass index.
Participants will provide clinical and lifestyle information and one stool sample for 16S ribosomal RNA gene sequencing and targeted tryptophan metabolite analysis.
No intervention will be assigned
|
Each participant will provide one stool sample.
Separate aliquots will be analyzed using 16S ribosomal RNA gene amplicon sequencing and targeted liquid chromatography-tandem mass spectrometry to characterize the gut microbiota and quantify prespecified tryptophan metabolites.
These analyses are conducted for research purposes only and will not be used for clinical diagnosis or treatment decisions.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Between-Group Differences in Fecal Tryptophan Metabolite Concentrations
기간: At enrollment, based on one stool sample collected from each participant
|
Fecal concentrations of tryptophan, kynurenine, kynurenic acid, quinolinic acid, indole-3-acetic acid, indole-3-lactic acid, indole-3-propionic acid, and tryptamine will be quantified using targeted liquid chromatography-tandem mass spectrometry.
Results will be reported as nanograms per gram or micromoles per kilogram of wet stool.
Matched between-group differences will be summarized using effect estimates, 95 percent confidence intervals, and Benjamini-Hochberg false discovery rate-adjusted results
|
At enrollment, based on one stool sample collected from each participant
|
|
Between-Group Difference in Fecal Microbial Community Structure
기간: At enrollment, based on one stool sample collected from each participant
|
Fecal microbial community structure will be characterized using Bray-Curtis and Aitchison beta-diversity metrics derived from 16S ribosomal RNA gene amplicon sequencing.
Differences between the Parkinson disease group and the matched healthy control group will be evaluated using permutational multivariate analysis of variance, with pair identification used to restrict permutations
|
At enrollment, based on one stool sample collected from each participant
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-0570
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .