CDI Synbiotic Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Dietary supplement: Synbiotic mixture; Other: Placebo comparator

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas M Petersen; Phone Number: 004538626199; Email: andreas.munk.petersen@regionh.dk
• Study Contact Backup: Name: Maria IC Rubin; Email: ingrid.maria.cecilia.rubin@regionh.dk

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Recruiting
    • Hvidovre Hospital
    • Contact: Andreas M Petersen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: probiotic arm; inulin, 15 g Lactobacillus rhamnosus (LGG®) Lactobacillus acidophilus (LA-5®) Lactobacillus paracasei (L. casei 431®) Bifidobacterium lactis (BB-12®), Total cell counts 150 billion/day	Dietary supplement: Synbiotic mixture; A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
Placebo Comparator: placebo arm; placebo powder, 15 g	Other: Placebo comparator; Placebo powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
toxin A and B levels measured by qPCR	1 year

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Principal Investigator: Andreas M Petersen, Gastrounit, Hvidovre Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: probiotics; prebiotics; synbiotics
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections
• Other Study ID Numbers: H-18041764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No