Landmark 139 · Trial in people

GUT-PARFECT faecal transplant

In 46 people, movement scores improved more with donor stool at 12 months. It is small, and later trials did not repeat it.

In short

A 46-person Belgian trial of donor gut bacteria showed a motor gain at 12 months in 2024, the only faecal transplant trial in this record with a positive primary result, though a Finnish trial of the same year (landmark 349) did not confirm it.

What it is
Trial in people
Outcome
Mixed or early results
When
2024
Size
46 people · Phase 2
Approach
Look beyond the brain
Research lane
Gut–brain origin
Trial registry
NCT03808389
Last checked
19 Oct 2026

The research record

This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".

Who

Annelies Bruggeman, Patrick Santens (corresponding author) and colleagues, Ghent University and University Hospital, Belgium (GUT-PARFECT). Funded by Flemish Parkinson's patient organisations (VPL, Parkili), Research Foundation Flanders and the Biocodex Microbiota Foundation.

What happened

  • GUT-PARFECT (eClinicalMedicine 71:102563, 27 March 2024; NCT03808389). Phase 2, single-centre, double-blind, run December 2020 to December 2022. 46 people with Parkinson's aged 50–65 (motor onset after 50) were randomised 1:1 to one nasojejunal transplant (200 ml) of donor stool (22) or their own stool as placebo (24); 43 had full data (21 and 22). Donor stool came from 17 healthy donors. The primary measure, off-medication MDS-UPDRS part III (motor), changed by −5.8 points (95% CI −11.4 to −0.2) with donor stool and −2.7 (−8.3 to 2.9) with placebo at 12 months (between-group p = 0.0235). Colon transit improved more with donor stool (p = 0.0252); fatigue scored worse (p = 0.0418); other measures did not differ. Mild, short-lived stomach symptoms in the first week occurred in 13 of 22 (59%) versus 6 of 24 (25%); there were no severe treatment-related events. The registry lists the study as completed, with no posted results.
  • Finnish trial. The same year's colonoscopic transplant trial found no benefit; see landmark 349.
  • Other trials. Two further faecal transplant trials have their own files: landmark 262 (EFFACE-PD, negative) and landmark 263 (Soroka pilot, no results).

Why it moved us toward a cure

Mice in landmark 56 suggested gut bacteria affect synuclein disease. GUT-PARFECT is the first randomised human test with a positive motor result. It is small and does not show disease slowing.

Outcome

Open and mixed. The result needs confirmation; the primary result sits at the edge of significance in a small trial, and the Warsaw trial (landmark 262) did not reproduce it. Neither tested whether decline was slowed.

Sources

How it connects

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