Bacteriotherapy in Pediatric Inflammatory Bowel Disease

• Sponsor: David Suskind (Other)
• Overall Status: Completed
• CT.gov ID: NCT01757964
• Collaborator: Seattle Children's Hospital (Other)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; CD	Biological: Bacteriotherapy	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bacteriotherapy in Pediatric Inflammatory Bowel Disease
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bacteriotherapy Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.	Biological: Bacteriotherapy

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 21 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• David Suskind
• Seattle Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Suskind, Associate Professor of Pediatrics, Seattle Children's Hospital
• ClinicalTrials.gov Identifier: NCT01757964
• Other Study ID Numbers: 14267
• First Posted: Dec 31, 2012
• Last Update Posted: May 30, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by David Suskind, Associate Professor of Pediatrics, Seattle Children's Hospital: Crohns Disease; Ulcerative Colitis; Inflammatory Bowel Disease; IBD
• Additional relevant MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer

Study Results

Participant Flow

Arm/Group Title	Bacteriotherapy: Crohn's Disease	Bacteriotherapy: Ulcerative Colitis
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	9	4
COMPLETED	9	4
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bacteriotherapy: Crohn's Disease	Bacteriotherapy: Ulcerative Colitis	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	9	4	13
Age (Count of Participants)
<=18 years	5 55.6%	4 100%	9 69.2%
Between 18 and 65 years	4 44.4%	0 0%	4 30.8%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	4 44.4%	0 0%	4 30.8%
Male	5 55.6%	4 100%	9 69.2%

Outcome Measures

1. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bacteriotherapy
Arm/Group Description	Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant. Bacteriotherapy
Measure Participants	13
Number [participants]	13 144.4%

Adverse Events

Arm/Group Title	Bacteriotherapy
Arm/Group Description	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.
All Cause Mortality
	Bacteriotherapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Bacteriotherapy
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Other (Not Including Serious) Adverse Events
	Bacteriotherapy
	Affected / at Risk (%)	# Events
Total	6/13 (46.2%)
Ear and labyrinth disorders
Rhinorrhea	1/13 (7.7%)	1
Gastrointestinal disorders
Abdominal pain	5/13 (38.5%)	5
Mild bloating	6/13 (46.2%)	6
Diarrhea	4/13 (30.8%)	4
Flatulence	2/13 (15.4%)	2
Sore throat	2/13 (15.4%)	2
Vomiting	2/13 (15.4%)	2
General disorders
Nasal congestion	1/13 (7.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.