A04.79 A04
Conditions
Interventions
Group 1: Luvos® Healing Earth imutox granules, (sachets) p.o. 3 x daily for 6 weeks. CE certified medical device CE0044
Group 2: Placebo granules, (sachets) p.o. 3 x daily for 6 weeks.
Sponsors
Heilerde-Gesellschaft Luvos Just GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Females and Males aged = 18 years with proven mild to moderate Clostridioides-difficile Infection (white blood cell count of < 15,000 cells/µl and a serum creatinine level < 1.5 mg/dl); Patients with a first or multiple relapses of CDI diagnosed by the primary care or hospital physician, and treated with anti-infectives (max. of 14 days) according to current guidelines, and which fulfil the criteria of "Clinical Cure".
Exclusion criteria
Exclusion criteria: Patients who need to continue taking their other therapies (except antibiotics) for any underlying conditions during the treatment phase, but who require a change in dose or medication during the treatment phase and/or concomitant therapy that, at the discretion of the investigator, precludes inclusion; Patients with short bowel syndrome or intestinal stomas; Patients with severe or complicated course of CDI; Patients who have to take antibiotics regularly, i.e., definitely or with a high probability during the study, due to other diseases; Patients who need to continue antibiotic therapy (beyond visit 1) due to infectious disease of other organs, or who have undergone antibiotic therapy (except against CDI) within the 4 weeks prior to inclusion (visit 1) in this study; Known allergic reactions to Healing Earth or other loess preparations; Patients with Crohn's disease and ulcerative colitis; Chronic liver disease (Child-Pugh B and C); Chronic renal insufficiency; Pregnancy or desire to become pregnant; Others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of a first or second CDI relapse, with a new episode of diarrhea, positive stool test for toxigenic C. difficile following clinical cure of the first infection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global cure, defined as clinical cure of the first infection or relapse episode and no further CDI relapse through week 6; Global cure, defined as clinical cure of the recurrent (Second/further) infection or relapse episode and no further CDI relapse through week 6; Overall clinical cure after first or further infection; Reduction of the patient's clinical symptoms in case of a further relapse episode; Safety: Adverse events. | — |
Countries
Germany, Romania
Outcome results
None listed