---
title: Improve constipation with fecal transplant
nct_id: NCT06388863
phase: NA
status: RECRUITING
sponsor: Shanghai Zhongshan Hospital
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT06388863"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06388863"
last_fetched: "2026-05-10T14:03:46.616Z"
source: "Parkinson's Pathways (curated)"
---
# Improve constipation with fecal transplant

**Goal (in five words):** Improve constipation with fecal transplant

**Official Title:** Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation

**Trial ID:** [NCT06388863](https://clinicaltrials.gov/study/NCT06388863)

## Key Facts

- **Phase:** NA
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Shanghai Zhongshan Hospital
- **Target Enrollment:** 76 participants
- **Start Date:** 2025-02-21
- **Completion Date:** 2026-12-31
- **Conditions:** Parkinson Disease
- **Interventions:** Healthy donor-derived FMT capsule, Placebo capsule
- **Intervention Types:** DRUG

## Summary For Families

Looking to see if giving healthy donor gut bacteria can relieve the chronic constipation many people with Parkinson's have, while checking safety and any ripple effects on Parkinson's symptoms. Treatment is oral capsules of donor-derived fecal microbiota or placebo, intended to reshape the gut microbiome to normalize bowel movements and reduce gut inflammation, and because gut bacteria can change levodopa absorption the trial requires stable Parkinson's medications so any changes can be tracked. Enrolling adults 40 to 75 with diagnosed PD at Hoehn-Yahr stage 1 to 3 who meet specific chronic constipation criteria, have been on stable anti-Parkinson meds, and who do not have recent antibiotics, major systemic illness, immunodeficiency, or other listed exclusions.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 75 Years
- **Sex:** ALL

### Full Criteria

```
Inclusion Criteria:

1. Participants who fulfill Chinese diagnostic criteria for PD (2016 edition), aged 40-75 years;
2. PD Hoehn-Yahr stage 1-3
3. Participants who have at least 2 of the following symptoms in the past 3 months and the symptoms have been present for at least 6 months: ① More than 25% of defecations are laborious; ② More than 25% of defecations consist of hard or lumpy stools; ③ More than 25% of defecations are accompanied by a sensation of incomplete evacuation; ④ More than 25% of defecations are accompanied by a sensation of anorectal obstruction; ⑤ More than 25% of defecations require manual assistance; ⑥ Less than 3 spontaneous bowel movements per week.
4. Have taken a stable dose of anti-Parkinson drugs, antidepressants and antipsychotics for at least 1 month;
5. Absence of red flags such as weight loss, hematochezia and exclusion of other diagnosis;
6. Have signed the informed consent and agree to participate in this study;

Exclusion Criteria:

1. Parkinsonism-plus syndrome;
2. Stroke, brain trauma or epilepsy;
3. Have undergone surgery intervention due to PD;
4. Pregnant, planning pregnancy or lactating;
5. Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
6. Immunodeficiency or treatment with immune-modulating medication;
7. Have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
8. Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
9. Use of probiotics or antibiotics within 1 month prior to study entry;
10. Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
```

## Locations (1)

- 180 Fenglin Road, Shanghai, Shanghai Municipality, China _(31.2222, 121.4581)_
  - Shengdi Wu — (CONTACT) — (86)13817923359 — wu.shengdi@zs-hospital.sh.cn
  - Shengdi Wu — (PRINCIPAL_INVESTIGATOR)

## Central Contacts

- Shengdi Wu — (CONTACT) — (86)13817923359 — wu.shengdi@zs-hospital.sh.cn
- Xinyi Liu — (CONTACT) — liu.xinyi2@zs-hospital.sh.cn

---

*Canonical: https://parkinsonspathways.com/trial/NCT06388863*  
*HTML version: https://parkinsonspathways.com/trial/NCT06388863*  
*Source data: https://clinicaltrials.gov/study/NCT06388863*