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

Not Applicable

• Conditions: Clostridium Difficile Infection
• Interventions: Biological: FMT-c Lactobacillus; Biological: FMT-c

• Registration Number: NCT03804736
• Lead Sponsor: Universidad Autonoma de Nuevo Leon

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.

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2018-06-30
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-01
• Last Update Posted: 2019-03-05
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 21

Inclusion Criteria

• Older than 18 years With recurrent CDI

Exclusion Criteria

Older than 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
decrease in the number of evacuations	up to two days	The cure of CDI was measured