Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, CD
Conditions
Keywords
Crohns Disease, Ulcerative Colitis, Inflammatory Bowel Disease, IBD
Brief summary
In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis. Additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric IBD.
Interventions
BIOLOGICALBacteriotherapy
Sponsors
Seattle Children's Hospital
David Suskind
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis or Crohn's Disease * Willing parent to donate stool for the transplant
Exclusion criteria
* Severe Disease * History of intra-abdominal abscess, intra-abdominal fistula or stricturing * History of other systemic diseases * The patient has received TNF inhibitors to treat their IBD within two months of transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring | 2 weeks | The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bacteriotherapy: Crohn's Disease Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit. | 9 |
| Bacteriotherapy: Ulcerative Colitis Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit. | 4 |
| Total | 13 |
Baseline characteristics
| Characteristic | Bacteriotherapy: Crohn's Disease | Bacteriotherapy: Ulcerative Colitis | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Female | 4 Participants | 0 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring
The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bacteriotherapy | Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring | 13 participants |