Trial Outcomes & Findings for Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea (NCT NCT01925417)

NCT ID: NCT01925417

Last Updated: 2019-11-13

Results Overview

Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 56 days
• Results posted on: 2019-11-13

Participant Flow

Recruitment was from 07/15/13 to 12/16/13 at 13 medical clinics in the United States. Recruiment was performed by trained investigators and study coordinators.

Participant milestones

Measure	RBX2660 (Microbiota Suspension) This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Overall Study STARTED	34
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	RBX2660 (Microbiota Suspension) This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Overall Study Withdrawal by Subject	2
Overall Study Death	1

Baseline Characteristics

Microbiota Restoration Therapy for Recurrent Clostridium Difficile-associated Diarrhea

Baseline characteristics by cohort

Measure	RBX2660 (Microbiota Suspension) n=34 Participants Open-label; all subjects received RBX2660
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	66.8 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 56 days

Population: 31 subjects had evaluable data at 56 days.

Safety will be assessed by evaluating the incidence of serious adverse events through 56 days after the last treatment with RBX2660.

Outcome measures

Measure	RBX2660 (Microbiota Suspension) n=31 Participants This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Incidence of Serious Adverse Events Through 56 Days After the Last Treatment With RBX2660	10 number of reported SAEs through 56 days

SECONDARY outcome

Timeframe: 6 months

Population: 31 subjects had evaluable data at 6 months.

The incidence of serious adverse events will be assessed through 6 months after the last treatment with RBX2660.

Outcome measures

Measure	RBX2660 (Microbiota Suspension) n=31 Participants This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Long-term Safety	20 number of reported SAEs

SECONDARY outcome

Timeframe: 56 days

Population: 31 subjects had evaluable data at 56 days.

Number of participants who were determined to be free of CDAD at Day 56 after receiving their last dose of RBX2660.

Outcome measures

Measure	RBX2660 (Microbiota Suspension) n=31 Participants This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Absence of CDAD at 56 Days	27 participants with treatment success

SECONDARY outcome

Timeframe: 60 days

Quality of Life (SF-36) will be assessed by comparing the subject's baseline quality of life score to his/her scores obtained at the 7-, 30- and 60-day follow-up visits.

The scale is from 0-100, with higher scores meaning better outcomes.

Outcome measures

Measure	RBX2660 (Microbiota Suspension) n=34 Participants This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Quality of Life (SF-36) Baseline	42.2 score on a scale Standard Deviation 14.6
Quality of Life (SF-36) 7-Day	47.7 score on a scale Standard Deviation 11.7
Quality of Life (SF-36) 30-DAy	48.6 score on a scale Standard Deviation 11.8
Quality of Life (SF-36) 60-Day	51.3 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: 6 months

Population: 31 subjects had evaluable data at 6 months.

number of ICU days was collected for subjects who received RBX2660 and who were subsequently hospitalized for recurrent CDAD treatment.

Outcome measures

Measure	RBX2660 (Microbiota Suspension) n=31 Participants This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Post-treatment Hospitalization Data	0 number of particpants' ICU days Interval 0.0 to 0.0

Adverse Events

RBX2660 (Microbiota Suspension)

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	RBX2660 (Microbiota Suspension) n=34 participants at risk This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Infections and infestations Clostridium difficile infection	8.8% 3/34 • Number of events 4 • From time of enrollment through the 6-month follow-up period.
Injury, poisoning and procedural complications Pelvic Fracture	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Urinary Tract Infection	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Pneumonia	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Clostridium difficile Colitis	2.9% 1/34 • Number of events 3 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Bacteraemia	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
General disorders Non-cardiac Chest Pain	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Surgical and medical procedures Chemotherapy	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.
Injury, poisoning and procedural complications Stab Wound	2.9% 1/34 • Number of events 1 • From time of enrollment through the 6-month follow-up period.

Other adverse events

Measure	RBX2660 (Microbiota Suspension) n=34 participants at risk This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
Gastrointestinal disorders Abdominal Distension	20.6% 7/34 • Number of events 9 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Abdominal Pain	29.4% 10/34 • Number of events 14 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Anorectal Discomfort	14.7% 5/34 • Number of events 6 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Constipation	23.5% 8/34 • Number of events 14 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Diarrhoea	29.4% 10/34 • Number of events 26 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Flatulence	38.2% 13/34 • Number of events 15 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Nausea	14.7% 5/34 • Number of events 5 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Proctalgia	5.9% 2/34 • Number of events 3 • From time of enrollment through the 6-month follow-up period.
Gastrointestinal disorders Vomiting	11.8% 4/34 • Number of events 5 • From time of enrollment through the 6-month follow-up period.
General disorders Chills	14.7% 5/34 • Number of events 5 • From time of enrollment through the 6-month follow-up period.
General disorders Fatigue	8.8% 3/34 • Number of events 3 • From time of enrollment through the 6-month follow-up period.
General disorders Pyrexia	11.8% 4/34 • Number of events 4 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Nasopharyngitis	5.9% 2/34 • Number of events 2 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Upper Respiratory Tract Infection	5.9% 2/34 • Number of events 3 • From time of enrollment through the 6-month follow-up period.
Infections and infestations Urinary Tract Infection	5.9% 2/34 • Number of events 2 • From time of enrollment through the 6-month follow-up period.
Metabolism and nutrition disorders Dehydration	5.9% 2/34 • Number of events 2 • From time of enrollment through the 6-month follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 2/34 • Number of events 2 • From time of enrollment through the 6-month follow-up period.
Nervous system disorders Headach	5.9% 2/34 • Number of events 3 • From time of enrollment through the 6-month follow-up period.
Nervous system disorders Anxiety	5.9% 2/34 • Number of events 2 • From time of enrollment through the 6-month follow-up period.

Additional Information

Sarah Mische PhD, Associate Director of Clinical Research

Rebiotix

Phone: 6512122839

Email: smische@rebiotix.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place