← Back to Search

Microbiota Therapy

FE 999322 for Ulcerative Colitis

Phase 1

Recruiting

Research Sponsored by Ferring Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 52

Awards & highlights

Study Summary

"This trial aims to test the safety of two different microbiota treatments compared to a placebo in people with mild to moderate ulcerative colitis."

Who is the study for?

Adults over 18 with a confirmed diagnosis of mild to moderate ulcerative colitis for more than three months are eligible for this trial. It's designed for those who have not found relief through standard treatments.Check my eligibility

What is being tested?

The trial is testing the safety and effects of two experimental treatments: FE 999322 (a microbiota suspension) and FE 999324 (a microbiota capsule), compared to placebo versions in adults with active ulcerative colitis.See study design

What are the potential side effects?

Potential side effects may include digestive discomfort, changes in bowel habits, abdominal pain, or reactions at the site of treatment. The full range of side effects will be studied as part of the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment-emergent adverse events from baseline to week 52

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: FE 999324Experimental Treatment1 Intervention

Microbiota capsule

Group II: FE 999322Experimental Treatment1 Intervention

Microbiota suspension

Group III: Placebo FE 999322Placebo Group1 Intervention

Placebo suspension

Group IV: Placebo FE 999324Placebo Group1 Intervention

Placebo capsule

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor

313 Previous Clinical Trials

440,768 Total Patients Enrolled

17 Trials studying Ulcerative Colitis

16,389 Patients Enrolled for Ulcerative Colitis

Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals

62 Previous Clinical Trials

357,305 Total Patients Enrolled

5 Trials studying Ulcerative Colitis

12,417 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective participants currently able to enroll in this medical study?

"Indeed, data from clinicaltrials.gov confirms the ongoing recruitment for this trial. The trial was first listed on March 12th, 2024 and last modified on April 3rd, 2024. Recruitment is underway to enroll a total of 90 participants across three designated sites."

Answered by AI

What is the current number of participants enrolled in this clinical study?

"Affirmative. Details on clinicaltrials.gov imply that this investigation is presently in search of suitable candidates. Initially shared on the 3rd of December, 2024 and most recently revised on April 3rd, 2024, the trial aims to recruit a total of 90 individuals across three designated sites."

Answered by AI

Has the drug FE 999322 received approval from the FDA?

"Given the preliminary nature of this investigation as a Phase 1 trial, our team at Power has assigned a safety rating of 1 to FE 999322 due to the scarcity of data supporting both its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06260267.