Trial document




drksid header

  DRKS00027358

Trial Description

start of 1:1-Block title

Title

Prospective, randomised, placebo-controlled, double-blind, multicentre clinical investigation to evaluate the clinical performance and safety of LUVOS® HEALING EARTH imutox treatment in patients with recurrent Clostridioides difficile infection. (2020-08, LUVCDI)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

2020-08 (LUVCDI)

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this randomized, placebo-controlled study, the efficacy, tolerability and side effect profile in patients with acute C. difficile infection and associated gastrointestinal symptoms, such as diarrhea, of the natural product Luvos® Healing Earth, which has been in use and marketed for over 100 years, will be demonstrated. In this context, Luvos® Healing Earth is used in the follow-up of a successful antibiotic therapy to prevent a flare-up of the infection and/or the symptoms.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The present clinical investigation will evaluate the toxin-binding effect of the well-characterized Healing Earth (Luvos® Healing Earth imutox), which is effective in the lumen of the intestine, in subjects with proven and antibiotically treated infection with Clostridioides difficile. Luvos® Healing Earth shows very good binding of toxin A (TcdA) in vitro, toxin B (TcdB) is less well bound in the presence of albumin. However, the albumin concentration in the faeces is low. In clinical practice, Healing Earth has shown to be effective in the treatment of milder cases of CDI. Subjects with confirmed CDI should be treated continuously with Luvos® Healing Earth p.o. for a period of 42 days after the current infection has been cured. Efficacy of Luvos® Healing Earth is expected based on the strong binding of bacterial toxins due to its ad- and absorption properties, thereby removing a substantial factor for flare-up and infection recurrence.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

Yes

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

IPD Plan: Yes. Timeframe: Data requests can be submitted starting 3 months after publication of the article. Data will be made available for up to 24 months. Extensions will be considered on a case-by-case basis.
Criteria for Access: Access to study IPD data may be requested by qualified investigators conducting independent scientific research and will be granted after review and approval of a research proposal and statistical analysis plan (SAP) and completion of a data sharing agreement. The sponsor reserves the right to exclude certain variables or data sets from sharing. For more information or to submit an application, please contact info at luvos.de.

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00027358
  •   2022/02/22
  •   [---]*
  •   no
  •   Approved
  •   2021-2392-evBO, Ethikkommission der Landesärztekammer Hessen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1273-0575 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   A04.79 -  [generalization A04.7: Enterocolitis due to Clostridium difficile]
  •   A04 -  Other bacterial intestinal infections
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Luvos® Healing Earth imutox granules, (sachets) p.o. 3 x daily for 6 weeks. CE certified medical device CE0044
  •   Placebo granules, (sachets) p.o. 3 x daily for 6 weeks.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, data analyst
  •   Placebo
  •   Prevention
  •   Parallel
  •   IV
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Occurrence of a first or second CDI relapse, with a new episode of diarrhea, positive stool test for toxigenic C. difficile following clinical cure of the first infection.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Global cure, defined as clinical cure of the first infection or relapse episode and no further CDI relapse through week 6; Global cure, defined as clinical cure of the recurrent (Second/further) infection or relapse episode and no further CDI relapse through week 6; Overall clinical cure after first or further infection; Reduction of the patient's clinical symptoms in case of a further relapse episode; Safety: Adverse events.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Romania
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2022/03/01
  •   314
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Females and Males aged ≥ 18 years with proven mild to moderate Clostridioides-difficile Infection (white blood cell count of < 15,000 cells/μl and a serum creatinine level < 1.5 mg/dl);
Patients with a first or multiple relapses of CDI diagnosed by the primary care or hospital physician, and treated with anti-infectives (max. of 14 days) according to current guidelines, and which fulfil the criteria of "Clinical Cure".

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patients who need to continue taking their other therapies (except antibiotics) for any underlying conditions during the treatment phase, but who require a change in dose or medication during the treatment phase and/or concomitant therapy that, at the discretion of the investigator, precludes inclusion; Patients with short bowel syndrome or intestinal stomas; Patients with severe or complicated course of CDI; Patients who have to take antibiotics regularly, i.e., definitely or with a high probability during the study, due to other diseases; Patients who need to continue antibiotic therapy (beyond visit 1) due to infectious disease of other organs, or who have undergone antibiotic therapy (except against CDI) within the 4 weeks prior to inclusion (visit 1) in this study; Known allergic reactions to Healing Earth or other loess preparations; Patients with Crohn's disease and ulcerative colitis; Chronic liver disease (Child-Pugh B and C); Chronic renal insufficiency; Pregnancy or desire to become pregnant; Others.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Heilerde-Gesellschaft Luvos Just GmbH & Co. KG
    • Ms.  Diplom-Volkswirtin  Ariane  Kaestner 
    • Otto-Hahn-Straße 23
    • 61381  Friedrichsdorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Heilerde-Gesellschaft Luvos Just GmbH & Co. KG
    • Otto-Hahn-Straße 32
    • 61381  Friedrichsdorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Privatpraxis
    • Ms.  Dr.  Julia  Kleinhenz 
    • Am Klingenweg 2a
    • 65396  Walluf
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Heilerde-Gesellschaft Luvos Just GmbH & Co. KG
    • Otto-Hahn-Straße 32
    • 61381  Friedrichsdorf
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Heilerde-Gesellschaft Luvos Just GmbH & Co. KG
    • Ms.  Diplom Volkswirtin  Ariane  Kaestner 
    • Otto-Hahn-Straße 32
    • 61381  Friedrichsdorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   2020-08 CIP V 1.1
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.