T78.1 T62 K58 K59
Conditions
Interventions
Group 1: Luvos® Healing Earth imutox Granules and Placebo Granules, 6.5 g p.o. 3 times daily for 6 weeks. CE certified medical device CE0044.
Group 2: Placebo Granules, 6.5 g p.o., 3 times daily for 6
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 recurrent upper or lower GI symptoms and known histamine pathophysiology in the gastrointestinal tract: Recurrent digestive symptoms for which, based on previous full GI-diagnostics no other cause could be identified, and Symptomatic and/or diagnostic findings supporting a histamine-mediated pathophysiology.
Exclusion criteria
Exclusion criteria: (1) Patients with severe allergic reactions (anaphylaxis, gastrointestinal mediated allergies grade IV); (2) Treatment with corticosteroids, immunosuppressant’s, biologics, chemotherapeutics; (3) Patients with short bowel syndrome, colon resection or intestinal stomas; (4) Therapy with antibiotics within 4 weeks prior to inclusion in the clinical investigation, or ongoing hyposensitization treatment; (5) Acute bacterial or viral infections that, at the discretion of the investigator, argues against inclusion of the patient in the clinical investigation; (6) Other acute or chronic medical conditions of the patient that, in the investigator's judgment, argues against inclusion of the patient in the clinical investigation; (7) Known allergic reactions to Healing Earth or other loess preparations; (8) Pregnancy; (9) Others.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the clinically significant reduction of clinical symptoms after 6 weeks of treatment with Luvos Healing Earth compared to placebo, as determined by a 10-item symptom scale (HIT-ISS10). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study objectives are the reduction of clinical symptoms as determined by different clinical scores (ISS-SSS, Erlangen), overall assessment by physician and patient (scale), assessment of QoL by SF12. In a subgroup of patients: lowering of histamine levels in stool, reduction of urine methylhistamine excretion and/or plasma and urine histamine concentrations before vs. after treatment. | — |
Countries
Germany
Outcome results
None listed