Trial Outcomes & Findings for Fecal Microbiota Transplant for Primary CDI (NCT NCT03795233)

Results Overview

The stool microbiome in participants who receive additional FMT at end of Clostridium difficile infection (CDI) treatment with oral vancomycin will be compared to the stool microbiome in participants with standard treatment or oral vancomycin alone

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

11 months

Results posted on

2021-12-15

Participant Flow

Participant milestones

Participant milestones
Measure	Fecal Microbiota Transplantation Fecal microbiota transplant (FMT) G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection. Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation	Oral Vancomycin Alone (Control) Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection. Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy.
Overall Study STARTED	4	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Fecal Microbiota Transplantation Fecal microbiota transplant (FMT) G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection. Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation	Oral Vancomycin Alone (Control) Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection. Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	0
Overall Study Death	1	0

Baseline Characteristics

Fecal Microbiota Transplant for Primary CDI

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fecal Microbiota Transplantation n=4 Participants Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection. Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation	Oral Vancomycin Alone (Control) n=1 Participants Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection. Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy.	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	49.8 years STANDARD_DEVIATION 11.9 • n=5 Participants	58 years n=7 Participants	51.4 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African Am	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 11 months

Population: This outcome measure was not obtained on any of the participants as no participant was in the study at 11 months.

The stool microbiome in participants who receive additional FMT at end of Clostridium difficile infection (CDI) treatment with oral vancomycin will be compared to the stool microbiome in participants with standard treatment or oral vancomycin alone

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: This outcome measure was not obtained on any of the participants as no participant was in the study at 12 months.

The number and proportion of FMT pills participants ingest after completion of a course of oral vancomycin therapy will be documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During test dose, during 90 minutes of FMT administration, 30 minutes after FMT administration, 48-72 hours after FMT administration

Population: Only one participant in the FMT arm ingested the intervention.

Study participants will be monitored for any adverse events to FMT such as nausea or vomiting, abdominal pain or diarrhea.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Transplantation n=1 Participants Fecal microbiota transplant G3 capsules will be administered after standard of care with oral vancomycin therapy in participants with primary Clostridium difficile infection. Fecal microbiota transplant G3 capsules: After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation	Oral Vancomycin Alone (Control) Oral vancomycin therapy will be administered as per standard of care in participants with primary clostridium difficile infection. Oral Vancomycin alone: Standard of care will be provided with oral vancomycin therapy.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of FMT After a Course of Oral Vancomycin Therapy	0 Participants	—

SECONDARY outcome

Timeframe: 60 days

Population: This outcome measure was not obtained on any of the participants.

A detailed survey with 15 questions will be administered on GI symptoms Physicians will go over any significant adverse events to determine if they are related, possibly related or unrelated to oral FMT administration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 60 days

Population: This outcome measure was not obtained on any of the participants.

Patients will be monitored for recurrent C difficile infection defined as non-resolution or recurrence of GI symptoms (abdominal pain, diarrhea etc) and/or a positive stool C difficile test The proportion of participants with CDI recurrence will be documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: This outcome measure was not obtained on any of the participants.

The number of hospital readmissions within 30 days after CDI treatment per patient history and chart review will be obtained

Outcome measures

Outcome data not reported

Adverse Events

Fecal Microbiota Transplantation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Oral Vancomycin Alone (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tamar Barlam, MD MSC

Boston Medical Center

Phone: 617 414 5190

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place