Clinical Trials Logo
  1. Home
  2. Clostridium Difficile Infection
  3. NCT03804736
  4. Details
NCT03804736 Clinical Trial

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

Clostridium Difficile Infection Clinical Trial

Official title:
Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection

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

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Completed NCT02214771 - Description of the Use of fidAxomicin in Hospitalized Patients With Documented Clostridium diFficile iNfection and of the managEment of These Patients N/A
Withdrawn NCT01552668 - Fidaxomicin to Prevent Clostridium Difficile Colonization Phase 4
Recruiting NCT03325855 - Fecal Microbiota Transplant National Registry
Not yet recruiting NCT03586206 - Relationship Between C. Difficile Toxins' Serum Level With C. Difficile Infection
Recruiting NCT03350711 - A Screening and Recruitment Study in Adults Expressing Interest in the Emory Microbiota Enrichment Program
Withdrawn NCT03643887 - Phase II Trial of Fecal Microbiota Transplant (FMT) for VRE and CRE Patients Phase 2
Terminated NCT04000555 - Oral Vancomycin for Secondary Prophylaxis of Clostridium Difficile Infection (CDI) Phase 4
Terminated NCT03065374 - Treatment for Clostridium-difficile Infection With IMM529 Phase 1/Phase 2
Completed NCT03710694 - Safety and Efficacy of DAV132 in Patients at High-Risk for Clostridium Difficile Infection (CDI) N/A
Completed NCT02865616 - MET-2 Clinical Study for Recurrent Clostridium Difficile Infection (CDI) Phase 1
Recruiting NCT04940468 - High- Fiber/ Low-fat Diet for Prevention of Recurrent Clostridioides Difficile Infection in Oncology N/A
Completed NCT02589847 - Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection Phase 2
Not yet recruiting NCT01942447 - Fecal Microbiota Transplantation in Recurrent or Refractory Clostridium Difficile Colitis N/A
Active, not recruiting NCT02086916 - Novel Biomarkers to Predict Outcome in Clostridium Difficile Infection N/A
Completed NCT01230957 - Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults Phase 2
Completed NCT01241552 - A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) Phase 3
Not yet recruiting NCT04567134 - Clostridioides Difficile Infection - a Prospective Nationwide Epidemiologic Study in Korea
Completed NCT04075422 - Bezlotoxumab - in "Real Life" - During the First Episode of Clostridium Difficile Infection in Patients With High Risk of Recurrence.
Recruiting NCT03712722 - Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Recruiting NCT05192148 - Seroprevalence of Antibodies to Surface Antigens and Toxins of Clostridioides Difficile N/A