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Bacteriotherapy in Pediatric Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT01757964
Recruitment Status : Completed
First Posted : December 31, 2012
Results First Posted : May 25, 2016
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
Seattle Children's Hospital
Information provided by (Responsible Party):
David Suskind, Seattle Children's Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
CD
Intervention Biological: Bacteriotherapy
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bacteriotherapy: Crohn's Disease Bacteriotherapy: Ulcerative Colitis
Hide 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
Arm/Group Title Bacteriotherapy: Crohn's Disease Bacteriotherapy: Ulcerative Colitis Total
Hide 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 Number of Baseline Participants 9 4 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 4 participants 13 participants
<=18 years
5
  55.6%
4
 100.0%
9
  69.2%
Between 18 and 65 years
4
  44.4%
0
   0.0%
4
  30.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 4 participants 13 participants
Female
4
  44.4%
0
   0.0%
4
  30.8%
Male
5
  55.6%
4
 100.0%
9
  69.2%
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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bacteriotherapy
Hide 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

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
13
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bacteriotherapy
Hide 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 (%)
Total   --/--    
Hide Serious Adverse Events
Bacteriotherapy
Affected / at Risk (%) # Events
Total   0/13 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bacteriotherapy
Affected / at Risk (%) # Events
Total   6/13 (46.15%)    
Ear and labyrinth disorders   
Rhinorrhea [1]  1/13 (7.69%)  1
Gastrointestinal disorders   
Abdominal pain [2]  5/13 (38.46%)  5
Mild bloating [3]  6/13 (46.15%)  6
Diarrhea [3]  4/13 (30.77%)  4
Flatulence  2/13 (15.38%)  2
Sore throat [4]  2/13 (15.38%)  2
Vomiting [5]  2/13 (15.38%)  2
General disorders   
Nasal congestion [6]  1/13 (7.69%)  1
[1]
Related to nasogastric tube placement. Self resolved.
[2]
Mild(4/5);moderate(1/5); all self resolving.
[3]
Mild self resolving.
[4]
Self resolving. Related to Nasogastric tube placement.
[5]
Episodes occurred greater than 4 hours after FMT. One related to 3 hour car ride after FMT the other associated with eating a large greasy meal after FMT.
[6]
mild self resolving related to the nasogastric tube placement
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Suskind MD Professor of Pediatrics
Organization: University of Washington
Phone: 206-987-2521
EMail: Jani.Klien@seattlechildrens.org
Layout table for additonal information
Responsible Party: David Suskind, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01757964    
Other Study ID Numbers: 14267
First Submitted: December 22, 2012
First Posted: December 31, 2012
Results First Submitted: November 16, 2015
Results First Posted: May 25, 2016
Last Update Posted: May 30, 2017