Prospective, randomized, double-blind, placebo-controlled, multicenter clinical investigation to determine the clinical performance and safety of Luvos® Healing Earth in patients with histamine-mediated recurrent digestive symptoms.

Phase 4

Recruiting

Conditions: T78.1
T62
K58
K59
Other adverse food reactions, not elsewhere classified
Toxic effect of other noxious substances eaten as food
Irritable bowel syndrome
Other functional intestinal disorders

Registration Number: DRKS00027333

Lead Sponsor: Heilerde-Gesellschaft Luvos Just GmbH % Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 114

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

(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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary study objectives are the reduction of clinical symptoms as determined by different clinical scores (ISS-SSS, Erlangen), <br>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.