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PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial (PediCRaFT)

Primary Purpose

Crohn Disease, Pediatric Crohns Disease, Inflammatory Bowel Diseases

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
MICROBIOTA
PLACEBO
Sponsored by
McMaster Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Paediatrics, Pediatrics, Crohn's, Crohn, Microbiome, Microbiota, FMT, Fecal Transplant, Fecal Microbiota Transplant, IBD-U, Inflammatory Bowel Disease Unclassified, Inflammatory Bowel Disease Indeterminate, IBD, Colitis

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients
  • ≥3yo
  • Crohn's disease, or IBD-Unclassified favoring Crohn's disease (as deemed by the patient's primary pediatric gastroenterologist)
  • Active symptoms

Exclusion Criteria:

  • Currently enrolled in another clinical trial
  • Unable to give informed consent or assent
  • Severe comorbid medical illness (at discretion of patient's primary pediatric gastroenterologist)
  • Concomitant Clostridium difficile infection
  • Severe Crohn's disease flare requiring hospitalization
  • Commenced new, or temporary medical therapies (ie. corticosteroids, antibiotics, prebiotics) within 4 weeks prior to commencing the trial; NB: Weaning doses of corticosteroid will be permitted (≤ 0.25mg/kg/day)

Sites / Locations

  • McMaster Children's Hospital
  • Centre Hospitalier Universitaire Sainte-Justine, University of Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MICROBIOTA

PLACEBO

Arm Description

Patients randomized to the INTERVENTION arm will receive a baseline fecal microbiota transplant (FMT) colonoscopic infusion at Week 0, followed by twice-weekly oral microbiota capsule (OMC) therapy for 6 weeks (including Week 0). (n = 30)

Patients randomized to the CONTROL arm will receive a baseline normal saline (NS) colonoscopic infusion at Week 0, followed by twice-weekly dextrose-containing oral placebo capsule (OPC) therapy for 6 weeks (including Week 0). (n = 15)

Outcomes

Primary Outcome Measures

Monthly Recruitment Rate
Assessment of recruitment rate (based on patients meeting all eligibility criteria who were approached for trial entry)
Dropout Rate Post Enrolment
Rate of patients leaving the trial (patient, or protocol directed exclusion) after enrolment
Rate of Patient Protocol Adherence
Rate of patients providing all required blood, stool and urine samples per protocol
Rate of Adverse Events
Rate of patients requiring hospitalization, or experiencing PCDAI increase ≥20 x 2 successive measures

Secondary Outcome Measures

Clinical: Improvement in Disease Symptoms
PCDAI decrease ≥15 from baseline: Week 6, Week 30
Clinical: Remission in Disease Symptoms
PCDAI ≤ 10: Week 6, Week 30
Clinical: Improvement in Serum Inflammatory Markers
Decrease C-reactive protein from baseline: Week 6, Week 30
Clinical: Improvement in Mucosal Inflammatory Markers
Decrease fecal calprotectin from baseline: Week 6, Week 30
Clinical: Change in Urine Metabolomics
Change in urine metabolite profile from baseline: Week 6, Week 30
Clinical: Change in Fecal Microbiome
Change in fecal 16s rRNA + metagenomics profile baseline: Week 6, Week 30

Full Information

First Posted
December 12, 2017
Last Updated
October 17, 2023
Sponsor
McMaster Children's Hospital
Collaborators
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03378167
Brief Title
PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial
Acronym
PediCRaFT
Official Title
PediCRaFT: Pediatric Crohn's Disease Fecal Microbiota Transplant Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
September 30, 2023 (Actual)
Study Completion Date
September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster Children's Hospital
Collaborators
St. Justine's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this study is to assess the feasibility of a novel colonic and oral fecal microbiota transplantation protocol for the treatment of active pediatric Crohn's disease (CD). Specifically, we will test the hypothesis that a protocol of combination fecal microbiota colonoscopic infusion and oral microbiota capsules (OMC), using live fecal material from anonymous unrelated donors, can improve the disease activity of pediatric CD patients.
Detailed Description
Several recent studies have assessed the role of fecal microbiota transplantation (FMT) in the treatment of inflammatory bowel disease (IBD). IBD is a chronic autoimmune gastrointestinal disorder that has been associated with disease-specific microbial signatures in the host. The vast majority of literature on the therapeutic role of FMT has assessed its role in the treatment of acute Clostridium difficile colitis, but its effectiveness at treating this disease condition suggests a central role of the microbiome in host immune tolerance. A. Alterations in the IBD Microbiome Investigators have characterized specific alterations of the gut microbiota in ulcerative colitis and Crohn's disease, compared to healthy controls. Patients with active IBD may have a relative depletion in anaerobic microbes, such as Bacteroides vulgatus, Lachnospiraceae (p: Firmicutes), and an increase in Proteobacteria and Bacillus (p: Firmicutes). These microbial signatures of IBD have led to several hypotheses about the protective, and pathological roles of different resident intestinal bacterial species. Conte et al have suggested that B. vulgatus may have a protective role against colitis, downregulating inflammation. Other studies have suggested that dysbiosis in IBD leads to decreased production of key short-chain fatty acids, such as butyric acid metabolized by Faecalibacterium prausnitzii. Directly, butyric acid and other short-chain fatty acids are key substrates absorbed by colonocytes, and indirectly, butyrate may inhibit inflammatory processes in the intestinal mucosa by suppressing cytokines, like interleukin-8. These studies have attempted to define canonical "intestinal-microbial-immune axes," supporting the hypothesis that IBD may occur secondary to an altered microbiome in a genetically, immunologically susceptible host. This constant host-microbial cross-talk may thus be altered by the introduction of key bacterial species that are otherwise absent, or decreased as a consequence of active mucosal inflammation, in the IBD gut. While FMT would not provide targeted, species-specific inoculations, whole stool transplant would theoretically introduce a broad range of bacteria, including those that are theoretically "favorable" to the host. B. The Pediatric Microbiome Pediatric IBD, and the pediatric microbiome, have several unique features that suggest microbial-based therapies could be particularly effective. Crohn's disease and ulcerative colitis typically have a much more aggressive course in the pediatric age group, suggesting that the pediatric IBD phenotype may have a pathophysiology that is distinct from adult-onset IBD. In pediatric IBD, the early age of onset makes the cumulative burden of medications, nutritional impairment, and surgery greater. Several standard IBD medication therapies have unique, age-specific toxicities in children. The overlap of pediatric chronic disease with critical periods of growth, bone accretion, and psychosocial development can make disease exacerbations disproportionately affect a child's long-term outcome. The pediatric microbiome itself has key differences. The shorter latency of disease may offer a unique window to reverse an underlying state of "dysbiosis." The pediatric microbiome may be more malleable than a fully defined adult microbiome, and the relatively immature immune system of children may be more influenced by FMT. C. FMT for the Treatment of Pediatric IBD Four case series have been published for the treatment of pediatric ulcerative colitis (UC) and CD using FMT. Protocols varied between all studies, and three main routes of administration were used: serial enemas, serial enemas with supplementary colonoscopic administration, and nasogastric tube. The first published study, involved five enemas administered daily to 9 UC patients, ages 7-21. Outcomes included clinical improvement from baseline using Pediatric Ulcerative Colitis Activity Index (PUCAI) scores, at one-week, and one-month post-treatment. 6/9 patients maintained clinical response at their one-month follow-up assessment. In 2015, two case series of FMT for CD and UC patients were published. A single FMT infusion was administered via nasogastric tube (NGT) to 4 UC, and 9 CD patients. No clinical response was seen in UC through NGT administration. In contrast, remission was induced in 7/9 CD patients within 2-weeks post-treatment, with 5/9 maintaining remission at week 6 and week 12. The most recent pediatric case series from 2015 included a cohort of pediatric UC patients treated with oral 5-ASA monotherapy, who received a combination of serial FMT enemas and colonoscopic infusions. 3 patients were included; 100% went into clinical remission at week 2, sustained clinical remission at week 4, and had complete withdrawal of immunotherapy at time of publication. Within the limitations of this small case series, there was a correlation between the number of FMT administrations, and the duration of remission. Two single-center pediatric case reports have recently been published showing marked clinical improvement in two patients with severe colitis. A 2015 case report describes a 4-month old female presenting with an early-onset colitis with UC-like phenotype. The patient was refractory to treatment with azathioprine and corticosteroids, and did not respond to further treatment with probiotics, a trial of amino-acid based formula, or infliximab. 2 serial FMT infusions with anonymous donor stool were administered via colonoscope, and a subsequent 5 infusions via nasoduodenal tube. These interventions led to clinical improvement, and complete resolution of histopathologic changes 6-months post FMT. A recent, 2016 case report describes an 11-year old female with corticosteroid-dependent UC who was unresponsive to treatment with 5-aminosalicylic acid and tacrolimus14. An initial FMT using her father's donor stool was performed via colonoscopy, and subsequent daily FMTs via fecal retention enema over the next 4 days, followed by 11 additional FMTs via retention enema every 2 to 4 weeks over 10 months. The patient remained in clinical remission at 40 weeks post final FMT, and showed complete endoscopic healing. D. Clinical Observations from Published Pediatric IBD FMT Studies Despite promising results, major drawbacks to these four pediatric studies include small sample sizes and their open label study design. Studies of clinical response demand a blinded study protocol, particularly given that many patients who enrol in FMT studies are a self-selected group, who already believe in the therapeutic value of "natural" treatments. Further, inflammatory bowel disease has well-described associations between clinical symptoms, mucosal disease activity and underlying stressors; thus, patient bias may have a significant influence on self-reported PUCAI/PCDAI (Pediatric Crohn's Disease Activity Index) scores when measuring clinical response. In addition, it is also important to note that success of FMT for IBD reflected in the aforementioned studies may reflect a propensity for studies with positive results to be published and unreported, unsuccessful studies may exist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Pediatric Crohns Disease, Inflammatory Bowel Diseases, Colitis
Keywords
Paediatrics, Pediatrics, Crohn's, Crohn, Microbiome, Microbiota, FMT, Fecal Transplant, Fecal Microbiota Transplant, IBD-U, Inflammatory Bowel Disease Unclassified, Inflammatory Bowel Disease Indeterminate, IBD, Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Patients will be randomized 2:1 to one of two groups upon consent: intervention or control. 30 patients will be randomized to receive an FMT via colonoscopy + oral microbiota capsular (OMC) therapy (INTERVENTION), and 15 patients will be randomized to receive normal saline (NS) via colonoscopy + dextrose-containing oral capsules (oral placebo capsule, OPC) (CONTROL). Randomization will occur through a computer-generated block-randomization pattern (block size = 6 participants). Patients randomized to the control group will be given the option of receiving open-label treatment, with the intervention therapy, either: upon completion of the trial, or if they are removed from the trial due to disease exacerbation or other adverse event, at the discretion of their primary gastroenterologist.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
COLONOSCOPY: Microbial enemas are drawn up in a 500cc syringe that is concealed with an opaque bag, used to infuse contents through the colonoscope. This will insure contents are blinded to non-study personnel in the room Patients randomized to the control study arm will have identical concealment of the 500cc syringe used to infuse contents through the colonoscope. For the NS infusion, study personnel will add an additional 0.75 ml of commercially available (Club House® brand), food-grade food coloring (2 drops red, 3 drops green, 7 drops yellow) to confer a brown color to the clear normal saline solution. This step will maintain blinding for the patient and non-study personnel in the room, as the contents of the liquid will be visible endoscopically, but will still retain a similarly-colored brown appearance akin to human stool. ORAL CAPSULAR THERAPY: a), b) The opaque color of both the OMC and OPC will insure that blinding is preserved to the study patient.
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MICROBIOTA
Arm Type
Experimental
Arm Description
Patients randomized to the INTERVENTION arm will receive a baseline fecal microbiota transplant (FMT) colonoscopic infusion at Week 0, followed by twice-weekly oral microbiota capsule (OMC) therapy for 6 weeks (including Week 0). (n = 30)
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the CONTROL arm will receive a baseline normal saline (NS) colonoscopic infusion at Week 0, followed by twice-weekly dextrose-containing oral placebo capsule (OPC) therapy for 6 weeks (including Week 0). (n = 15)
Intervention Type
Biological
Intervention Name(s)
MICROBIOTA
Other Intervention Name(s)
RBX2660, RBX7455, Fecal microbiota transplant
Intervention Description
Fecal microbiota enema (RBX2660) infused via colonoscope x 1 + oral microbiota capsules (RBX7455) x 6 weeks. The fecal microbiota enema (RBX2660) prepared by Rebiotix has received Health Canada Clinical Trials Application (CTA), and U.S. Food and Drug Administration Investigational New Drug Application (IND) approval for clinical trials in patients with recurrent Clostridium difficile infection, and pediatric inflammatory bowel disease. The human-derived fecal oral microbiota capsule (RBX7455) has received U.S. Food and Drug Administration Investigational New Drug Application (IND) approval for clinical trials in patients with recurrent Clostridium difficile infection.
Intervention Type
Biological
Intervention Name(s)
PLACEBO
Intervention Description
Placebo enema (Normal Saline) infused via colonoscope x 1 + oral placebo capsules (dextrose-containing capsules) x 6 weeks. NOTE: Patients randomized to the control group will be given the option of receiving open-label treatment, with the intervention therapy, either: upon completion of the trial, or if they are removed from the trial due to disease exacerbation or other adverse event, at the discretion of their primary gastroenterologist.
Primary Outcome Measure Information:
Title
Monthly Recruitment Rate
Description
Assessment of recruitment rate (based on patients meeting all eligibility criteria who were approached for trial entry)
Time Frame
30 weeks
Title
Dropout Rate Post Enrolment
Description
Rate of patients leaving the trial (patient, or protocol directed exclusion) after enrolment
Time Frame
30 weeks
Title
Rate of Patient Protocol Adherence
Description
Rate of patients providing all required blood, stool and urine samples per protocol
Time Frame
30 weeks
Title
Rate of Adverse Events
Description
Rate of patients requiring hospitalization, or experiencing PCDAI increase ≥20 x 2 successive measures
Time Frame
30 weeks
Secondary Outcome Measure Information:
Title
Clinical: Improvement in Disease Symptoms
Description
PCDAI decrease ≥15 from baseline: Week 6, Week 30
Time Frame
Baseline, Week 6, Week 30
Title
Clinical: Remission in Disease Symptoms
Description
PCDAI ≤ 10: Week 6, Week 30
Time Frame
Week 6, Week 30
Title
Clinical: Improvement in Serum Inflammatory Markers
Description
Decrease C-reactive protein from baseline: Week 6, Week 30
Time Frame
Baseline, Week 6, Week 30
Title
Clinical: Improvement in Mucosal Inflammatory Markers
Description
Decrease fecal calprotectin from baseline: Week 6, Week 30
Time Frame
Baseline, Week 6, Week 30
Title
Clinical: Change in Urine Metabolomics
Description
Change in urine metabolite profile from baseline: Week 6, Week 30
Time Frame
Baseline, Week 6, Week 30
Title
Clinical: Change in Fecal Microbiome
Description
Change in fecal 16s rRNA + metagenomics profile baseline: Week 6, Week 30
Time Frame
Baseline, Week 6, Week 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric patients ≥3yo Crohn's disease, or IBD-Unclassified favoring Crohn's disease (as deemed by the patient's primary pediatric gastroenterologist) Active symptoms Exclusion Criteria: Currently enrolled in another clinical trial Unable to give informed consent or assent Severe comorbid medical illness (at discretion of patient's primary pediatric gastroenterologist) Concomitant Clostridium difficile infection Severe Crohn's disease flare requiring hospitalization Commenced new, or temporary medical therapies (ie. corticosteroids, antibiotics, prebiotics) within 4 weeks prior to commencing the trial; NB: Weaning doses of corticosteroid will be permitted (≤ 0.25mg/kg/day)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikhil Pai, BSc, CNSC, MD, FRCPC
Organizational Affiliation
McMaster Children's Hospital, Division of Pediatric Gastroenterology & Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
M8V1A4
Country
Canada
Facility Name
Centre Hospitalier Universitaire Sainte-Justine, University of Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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PediCRaFT: Pediatric Crohn's Disease Fecal Transplant Trial

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