Clostridium Difficile Infection
Conditions
Brief summary
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection
Detailed description
Investigators designed an open, two-arm study to compare to compare fecal microbiota transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile recurrent infection. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.
Interventions
BIOLOGICALFMT-c Lactobacillus
Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
BIOLOGICALFMT-c
Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)
Sponsors
Universidad Autonoma de Nuevo Leon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients were randomized by a closed envelope method in a 1: 1 ratio to either FMT-c (15 capsules every 12 h by 2 days) or a FMT-c and Lactobacillus (15 capsules every 12 h by 2 days)
Eligibility
Healthy volunteers
No
Inclusion criteria
* Older than 18 years With recurrent CDI
Exclusion criteria
Older than 18 years \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| decrease in the number of evacuations | up to two days | The cure of CDI was measured |
Outcome results
None listed