NCT03104036 - Fecal Microbiota Transplantation (FMT) vs 5-Aminosalicylic Acid / Mesalazine & Ulcerative Colitis (UC)

Study overview:

NCT03104036 - Fecal Microbiota Transplantation (FMT) vs 5-Aminosalicylic Acid / Mesalazine & Ulcerative Colitis (UC) is a multicenter, open-label, noninferiority trial to evaluate Fecal Microbiota Transplantation (FMT) or 5-Aminosalicylic Acid / Mesalazine in 45 randomized patients with active left-sided Ulcerative Colitis (UC) (Mayo score 4–10) (1).

Primary outcome measures:

Clinical remission, with a total Mayo score ≤ 2 at week 12 with no subscore >1 (1).

Results:

Twelve FMT (57%) and eight 5-ASA patients achieved the primary study endpoint. FMT noninferiority with 10% margin was confirmed (95% CI: −7.6%, 48.9%) (1).

Conclusion:

FMT works well for treating left-sided UC and helps increase the variety of bacteria in the recipient's gut. Changing the microbiome in a specific way might make FMT work even better. More research is needed to help choose the right donors and patients (1)

The preliminary results indicate that FMT as non-drug-using method is thought to be a promising treatment for UC patients (2).

References:

(1) Březina et al. 2021 J Clin Med 10: 2753
(2) Schierova et al. 2020 Cells 9(10): 2283