Prospective, randomized, double-blind, placebo-controlled multi-center clinical investigation to determine the clinical performance and safety of Luvos® Healing Earth magenfein in patients with diarrhea-dominant irritable bowel syndrome (IBS-D).

Prospective, randomized, double-blind, placebo-controlled multi-center clinical investigation to determine the clinical performance and safety of Luvos® Healing Earth magenfein in patients with diarrhea-dominant irritable bowel syndrome (IBS-D). - 2020-12 (LUVIBS-D)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027633

Enrollment

Registered

2022-02-22

Start date

2022-03-31

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 K59 K30

Interventions

Group 1: Luvos® Healing Earth microfein (sachets) p.o. 3 x daily p.o. for 6 weeks. CE certified medical device CE0044. Group 2: Placebo (sachets) p.o. 3 x daily p.o. for 6 weeks. Group 3: Optional ext

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients of both sexes aged =18 and = 75 years; 2. IBS-D diagnosis confirmed according to Rome IV criteria based on guideline-compliant colon examination including histology (step biopsies; colonoscopy including biopsy) within 5 years prior to inclusion, and without relevant change in symptoms; 3. Assessment of IBS-D symptomatology by median stool frequency, stool consistency level 6/7 Bristol Stool Scale, and by IBS-SSS 4. Exclusion of chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease, microscopic colitis); 5. Presence of a consent form signed by the patient; 6. Willingness to avoid changes in lifestyle and dietary habits during the clinical investigation period; 7. Others.

Exclusion criteria

Exclusion criteria: Exclusion of various diseases, medications and general history.

Design outcomes

Primary

Measure	Time frame
Change in stool frequency in the last 14 days of the treatment phase (after 6 weeks (V4)) compared to the last 14 days of the screening phase, each measured as mean number of available stools per day.	—

Secondary

Measure	Time frame
Change in frequency of stool consistencies of type 6/7 in the last 14 days of the treatment phase (after 6 weeks (V4)) compared to the last 14 days of the screening phase, each measured as mean number per day of stools of consistencies using the Bristol stool scale; Change in bloating between day 0 and day 42 and daily severity of abdominal pain; Change in the severity of irritable bowel symptoms from visit 1 to visit 4 and severity of symptoms at the individual visits V2 and V3 determined via the IBS-SSS (IBS Severity Scoring System); Change in quality of life from visit 1 to visit 4 and quality of life to individual visits 2 and 3 as determined by SF12; Overall assessment of clinical performance by the investigator and patients at visits 2, 3, and 4; Time to early discontinuation (due to lack of efficacy) in days, prior to V4; Exploratory recording of symptoms for irritable stomach in the subgroup of patients with associated coexistent irritable stomach in addition to the diagnosis of irritable bowel syndrome; Others.	—

Measure

Time frame

Change in frequency of stool consistencies of type 6/7 in the last 14 days of the treatment phase (after 6 weeks (V4)) compared to the last 14 days of the screening phase, each measured as mean number per day of stools of consistencies using the Bristol stool scale; Change in bloating between day 0 and day 42 and daily severity of abdominal pain; Change in the severity of irritable bowel symptoms from visit 1 to visit 4 and severity of symptoms at the individual visits V2 and V3 determined via the IBS-SSS (IBS Severity Scoring System); Change in quality of life from visit 1 to visit 4 and quality of life to individual visits 2 and 3 as determined by SF12; Overall assessment of clinical performance by the investigator and patients at visits 2, 3, and 4; Time to early discontinuation (due to lack of efficacy) in days, prior to V4; Exploratory recording of symptoms for irritable stomach in the subgroup of patients with associated coexistent irritable stomach in addition to the diagnosis of irritable bowel syndrome; Others.

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Countries

Germany

Outcome results

None listed

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