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Microbiome study (cross-over): Influence of Regulat Essence 2.0 on the diversity of the intestinal microbiome, digestive symptoms and parameters of metabolic syndrome.

Microbiome study (cross-over): Influence of Regulat Essence 2.0 on the diversity of the intestinal microbiome, digestive symptoms and parameters of metabolic syndrome. - Microbiome Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037269
Enrollment
30
Registered
2026-02-11
Start date
2025-07-16
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

K58

Interventions

Group 1: 2 servings (20 ml each) of Regulat Essence 2.0 per day for 4 weeks - 4 weeks wash out period - 2 servings (20 ml each) of lactic acid per day for 4 weeks Group 2: 2 servings (20 ml each) of l

Sponsors

Dr. Niedermaier Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Gastrointestinal complaints (chronic and/or acute) - Symptoms of irritable bowel syndrome or leaky gut syndrome

Exclusion criteria

Exclusion criteria: - Capillary blood sampling not possible - Coagulation disorder or anticoagulant medication - Pregnancy/breastfeeding - Medication that affects lipid or cholesterol metabolism - Blood pressure medication - Blood sugar medication - Antibiotic use in the last 4 weeks - Use of cortisone/glucocorticoids - Regular use of dietary supplements or foods to support intestinal flora/microflora - Use of a pacemaker - Diagnosed diseases of the gastrointestinal tract (tumors, chronic inflammatory bowel disease, celiac disease, short bowel syndrome, gastric bypass)

Design outcomes

Primary

MeasureTime frame
Change in the diversity of the gut microbiota and gastrointestinal symptoms with improvement in parameters associated with leaky gut.

Secondary

MeasureTime frame
Changes in the following parameters: BMI, waist-to-hip ratio, blood pressure, fasting blood sugar, triglycerides, cholesterol (HDL, LDL, total), CRP, hsCRP, body composition. Polyphenols in urine and telomere length in sputum are also being analyzed.

Countries

Germany

Contacts

Public ContactSandra Habicht

Institut für Ernährungswissenschaft, Justus Liebig Universtät Giessen

sandra.habicht@uni-giessen.de06419939046

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026