Not provided
Not provided
Not provided
Not provided
Not provided
Investigators are no longer considering FMT product development for C. difficile.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection
This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low fecal microbiota dose | Active Comparator | receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days |
|
| Mid fecal microbiota dose | Active Comparator | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment |
|
| High fecal microbiota dose | Active Comparator | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low fecal microbiota dose | Biological | receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Assessed by Number of Participants With Nausea | 180 days | |
| Safety as Assessed by Number of Participants With Vomiting | 180 days | |
| Safety as Assessed by Number of Participants With Diarrhea | 180 days | |
| Safety as Assessed by Number of Participants With Bloating | 180 days | |
| Safety as Assessed by Number of Participants With Constipation | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrent C. Difficile Infection | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Herbert L DuPont, MD | UTHealth School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
2 of the 17 enrolled did not start treatment: one did not start treatment due to physician's concerns about patient taking bowel prep, and the second did not start treatment because of hospitalization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Low Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days |
| FG001 | Mid Fecal Microbiota Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Mid fecal microbiota dose | Biological | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment |
|
|
| High fecal microbiota dose | Biological | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days |
|
|
receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment |
| FG002 | High Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days |
| BG001 | Mid Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment |
| BG002 | High Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Number of Patients with Inflammatory bowel disease | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety as Assessed by Number of Participants With Nausea | Posted | Count of Participants | Participants | 180 days |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Safety as Assessed by Number of Participants With Vomiting | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Safety as Assessed by Number of Participants With Diarrhea | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Safety as Assessed by Number of Participants With Bloating | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Safety as Assessed by Number of Participants With Constipation | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrent C. Difficile Infection | Posted | Count of Participants | Participants | 6 months |
|
|
6 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days Low fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days | 0 | 4 | 1 | 4 | 1 | 4 |
| EG001 | Mid Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment Mid fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment | 0 | 3 | 0 | 3 | 3 | 3 |
| EG002 | High Fecal Microbiota Dose | receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days High fecal microbiota dose: receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days | 0 | 8 | 0 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Systematic Assessment | 60 days after Fecal microbiota transplantation (FMT), stool C. difficile toxin was negative but diarrhea continued. 3 months later, subject had colon removed because of ulcerative colitis and was released from the hospital 3 days after colon removal. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| bloating | Gastrointestinal disorders | Systematic Assessment |
| ||
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
Early termination leading to small numbers of subjects analyzed
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Herbert DuPont | UTexas_Houston | 713-500-9366 | herbert.l.dupont@uth.tmc.edu |
| Feb 19, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|