A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06260267

Enrollment

Registered

2024-02-15

Start date

2024-03-12

Completion date

2026-01-15

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Brief summary

To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).

Interventions

DRUGMicrobiota suspension

Microbiota suspension

DRUGMicrobiota capsule

Microbiota capsule

DRUGPlacebo suspension

Placebo suspension

DRUGPlacebo capsule

Placebo capsule

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject aged ≥18 at screening * Established diagnosis of ulcerative colitis by standard clinical, endoscopic and histological criteria, for more than 3 months at screening

Exclusion criteria

* Active disease or history of Crohn's disease * Active disease or history of irritable bowel syndrome (IBS) or any other chronic intestinal disease apart from UC * Active gastrointestinal infection.

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events from baseline to week 52	From baseline to week 52

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026