SymSF2

Randomized, double-blind, placebo-controlled, multi-centre trial to evaluate the efficacy, safety and tolerability of oral treatment with living bacteria of E. coli DSM 17252 (Symbioflor®2) in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D)

01/02/2022 to 31/01/2024

Objective: To investigate the effectiveness of oral treatment with Symbioflor®2 in patients with IBS-D compared to placebo in the improvement of the frequency and severity of IBS-D symptoms; To determine the safety and tolerability of Symbioflor®2

Number of Patients: Planned number of patients randomized: 422 (211 per treatment arm)

Investigational Medicinal Product (IMP): Symbioflor® 2 suspension; 1 mL (14 drops) contains cells of 1.5-4.5 x 107 living bacteria of Escherichia coli DSM 17252.

Dose and Route of Administration: 10 drops three times daily (TID) during week 1; 20 drops TID from week 2 to week 26 to be taken orally with meals

Reference therapy: Matching placebo suspension in identical appearance to Symbioflor® 2

Treatment duration: Two weeks of drug-free run-in for symptom assessment, 26 weeks of drug/placebo treatment, 4 weeks of follow-up, with regular visits in the trial sites, and daily diary control for symptoms

Trial duration per patient: The overall trial duration for each patient can be up to 32 weeks including the follow up

Planned trial period: Planned recruitment duration: 36 months