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

Universidad Autonoma de Nuevo Leon

Status: Unknown

Conditions: Clostridium Difficile Infection

Treatments: Biological: FMT-c Lactobacillus; Biological: FMT-c

Study type: Interventional

Funder types: Other

Identifiers

NCT03804736

IF-0016-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Older than 18 years With recurrent CDI

Exclusion Criteria:Older than 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

FMT-c

Active Comparator group

Description:

Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)

Treatment:

Biological: FMT-c

FMT-c lactobacillus

Experimental group

Description:

Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)

Treatment:

Biological: FMT-c Lactobacillus