ProjectSymSF2 – Randomized, double-blind, placebo-controlled, multi-centre trial to evaluate the efficacy, safety and…

Basic data

Acronym:
SymSF2
Title:
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)
Duration:
01/02/2022 to 31/01/2024
Abstract / short description:
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
Keywords:
Reizdarmsyndrom
Probiotikum
Darm-Gehirn-Achse

Involved staff

Managers

Faculty of Medicine
University of Tübingen

Contact persons

Faculty of Medicine
University of Tübingen

Other staff

Faculty of Medicine
University of Tübingen

Local organizational units

Department VI, Psychosomatics
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
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