Clinical Trials Directory

Trials / Unknown

UnknownNCT03804736

Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection

Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Universidad Autonoma de Nuevo Leon · Academic / Other
Sex
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALFMT-cPatients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)
BIOLOGICALFMT-c LactobacillusPatients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)

Timeline

Start date
2016-11-01
Primary completion
2018-06-30
Completion
2019-12-01
First posted
2019-01-15
Last updated
2019-03-05

Source: ClinicalTrials.gov record NCT03804736. Inclusion in this directory is not an endorsement.