Healing Earth and its role in gastrointestinal diseases: influence of treatment with Luvos® Heilerde on the intestinal microbiome in healthy individuals, in patients with irritable bowel syndrome (IBS) and in patients with liver cirrhosis and concomitant minimal hepatic encephalopathy – the ARENA - Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00032274

Enrollment

Registered

2023-07-13

Start date

2021-05-20

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K58 K74

Interventions

Group 1: Healthy individuals (Microbiota analysis before, during and after a 6 week therapy with Luvos Heilerde) Group 2: Patients with diarrhea-predominant IBS (Microbiota analysis before, during a

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: - Diarrhea-predominant IBS patients according Rome IV criteria - Patients with liver cirrhosis and minimal hepatic encephalopathy - Healthy controls without diagnosis of functional gastrointestinal diseases, neurodegenerative diseases, tumor disease in the last 5 years, severe metabolic or cardiovascular disease requiring therapy

Exclusion criteria

Exclusion criteria: 1. Documented underlying allergic condition against Healing Earths 2. Antibiotic treatment within 28 days before study entry or during the study 3. Individuals who are not in sufficient health status as determined by the outcome of medical history, physical assessment, and clinical judgment of the investigator 4. Individuals who are not able to follow the required study procedures for the entire period of the study 5. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject´s ability to participate in the trial. 6. Individuals who are planned to be hospitalized or undergo bowel cleansing or major surgery during the study period 7. Female subjects with childbearing potential who have positive pregnancy test during screening period. Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Analysis of the intestinal microbiome in healthy individuals (ARENA 1), in IBS patients with predominant diarrhea (IBS-D) (ARENA 2) and in patients with liver cirrhosis with concomitant minimal hepatic encephalopathy (ARENA 3) before, during and after consumption of Luvos Healing Earth.	—

Secondary

Measure	Time frame
Analysis of the effect of Luvos Healing Earth on IBS symptoms or on minimal hepatic encephalopathy.	—

Countries

Germany

Contacts

Public ContactRiccardo Vasapolli

Medizinische Klinik und Poliklinik 2, LMU Klinikum

riccardo.vasapolli@med.uni-muenchen.de+49 89 44000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026