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

Universidad Autonoma de Nuevo Leon21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Clostridium Difficile Infection

Interventions

FMT-cBIOLOGICAL

Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)

FMT-c LactobacillusBIOLOGICAL

Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Older than 18 years With recurrent CDI Exclusion Criteria:Older than 18 years \-

Outcomes

Primary Outcomes

decrease in the number of evacuations

The cure of CDI was measured

Time frame: up to two days

Data from ClinicalTrials.gov

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