Fecal Microbiota Transplant by Oral Capsules With Lactoba... | NCT03804736

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

NCT03804736

Sponsor

Universidad Autonoma de Nuevo Leon

Status

Unknown status

Last Update Posted

Mar 5, 2019Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Clostridium Difficile Infection

Interventions

FMT-c
FMT-c Lactobacillus

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2016

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Dec 1, 2019Estimated

First Submitted Date

Jan 11, 2019

First Submission Date that Met QC Criteria

Jan 11, 2019

First Posted Date

Jan 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2019

Last Update Posted Date

Mar 5, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adrián Camacho-Ortiz, Principal Investigator, Universidad Autonoma de Nuevo LeonPrincipal Investigator

Lead Sponsor

Universidad Autonoma de Nuevo LeonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMT-c	Active Comparator	Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)	Biological: FMT-c
FMT-c lactobacillus	Experimental	Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)	Biological: FMT-c Lactobacillus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FMT-c	Biological	Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)	FMT-c

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
decrease in the number of evacuations	The cure of CDI was measured	up to two days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years With recurrent CDI

Exclusion Criteria:Older than 18 years

Accepts Healthy Volunteers

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003015	Clostridium Infections

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

Masking Description

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)

Who Masked

Participant