CDI Synbiotic Study

Clostridium Difficile Infection Clinical Trial

Official title:

The Effectiveness of a Synbiotic Mixture (Inulin, Lactobacillus Rhamnosus (LGG®), Lactobacillus Acidophilus (LA-5®), Lactobacillus Paracasei, and Bifidobacterium Lactis (BB-12®)), on Decreasing Recurrence of Clostridium Difficile Associated Diarrhea- a , Randomized, Placebo-controlled Study With 4 Weeks Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012788
• Other study ID #: H-18041764
• Status: Recruiting
• Phase: N/A
• Start date: July 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2019
• Source: Hvidovre University Hospital
• Contact: Andreas M Petersen
• Phone: 004538626199
• Email: andreas.munk.petersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Description:

Probiotics have been tested for their efficacy in preventing infection with C. difficile after antibiotic exposure. Some of the most effective probiotics tested Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®). However, most studies have focused on prevention of the first incidence of C. difficile infection rather than prevention of re-infection with C. difficile. Recurrence rates of C. difficile infection (CDI) among hospitalized patients are 15-25% - either as relapses caused by the original organism or re-infection following treatment. The potential of probiotics in preventing re-infection is less studied in these patients. Further, prebiotics which are carbohydrates only metabolized by beneficial bacteria have gained much attention the recent years for their health benefits through stimulating growth of specific types of bacteria in the gut, and recent data from mouse studies show that the prebiotic inulin can eliminate C. difficile growth, but the use of prebiotics in relation to C. difficile elimination has yet to be proven in humans. The investigators hypothesize that treatment with a synbiotic mixture consisting of inulin Lactobacillus rhamnosus (LGG®), Lactobacillus acidophilus (LA-5®), Lactobacillus paracasei (L. casei 431®) and Bifidobacterium lactis (BB-12®) can reduce the number of C. difficile recurrences significantly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with primary CDI

• Treatment with Vancomycin

• Subjects over 18 years of age

• Signed informed consent

Exclusion Criteria:

1. Chemotherapy within two months and an absolute neutrophil count of < 1000 neutrophiles/mm3

2. Acute leukemia

3. Serious immunodeficiency

4. Pancreatitis

5. Planned or recent intraabdominal operation within a time window of 14 days

6. Terminal disease with expected survival time < 3 month

7. Probiotic consumption within two weeks prior enrollment

8. Pregnant or lactating women

9. A history of inflammatory or irritable bowel disease

10. Colectomy and cirrhosis

11. Septicemia

12. Toxic megacolon

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections

Intervention

Dietary Supplement:
• Synbiotic mixture
A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)

Other:
• Placebo comparator
Placebo powder

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced recurrence of C. difficile-associated diarrhoea (CDAD) after 8 weeks	telephone questionnaire with patient at end of trial as well as examination of each patient's medical record	1 year
Secondary	toxin A and B levels measured by qPCR		1 year