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

NCT ID: NCT03804736

Last Updated: 2019-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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

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Clostridium Difficile Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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)

Study Groups

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FMT-c

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

Group Type ACTIVE_COMPARATOR

FMT-c

Intervention Type BIOLOGICAL

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

FMT-c lactobacillus

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

Group Type EXPERIMENTAL

FMT-c Lactobacillus

Intervention Type BIOLOGICAL

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

Interventions

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FMT-c

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

Intervention Type BIOLOGICAL

FMT-c Lactobacillus

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Older than 18 years With recurrent CDI

Exclusion Criteria

\-
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Nuevo Leon

OTHER

Sponsor Role lead

Responsible Party

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Adrián Camacho-Ortiz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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IF-0016-3

Identifier Type: -

Identifier Source: org_study_id

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