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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03804736
Other study ID # IF-0016-3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2016
Est. completion date December 1, 2019

Study information

Verified date March 2019
Source Universidad Autonoma de Nuevo Leon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 21
Est. completion date December 1, 2019
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Older than 18 years With recurrent CDI

Exclusion Criteria:Older than 18 years

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autonoma de Nuevo Leon

Outcome

Type Measure Description Time frame Safety issue
Primary decrease in the number of evacuations The cure of CDI was measured up to two days
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