Holiday: Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT03476317
Collaborator
University of Pennsylvania (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
10
1
3
29.7
0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Investigators will evaluate the efficacy of a novel treatment regimen, employing non-immunosuppressive medications, in the management of refractory CD or IBDU. Refractory patients include those patients who have experienced loss of responsiveness (LOR) or primary nonresponse to an immunomodulator or a biologic. Investigators will treat participants with a combination of gut microbiota-targeted therapies to restore a healthy gut microbiome composition. Investigators believe that this strategy will both treat the gut inflammation associated with inflammatory bowel disease (IBD) as well as salvage response to immune suppressive therapies.

Investigators will also evaluate the effect of PEG lavage alone on fecal calprotectin and gut microbiota. Participants in this arm, will be undergoing a PEG lavage in preparation for a endoscopy for clinical care. They will be asked to provide stool samples, prior to and after their PEG lavage. Participants will not be receiving any investigational treatments.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Actual Study Start Date :
Jul 12, 2018
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1-Fluconazole

Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14).

Drug: Vancomycin
Oral suspension 4 times daily (Day 1-14)
Other Names:
  • Vancocin
  • Drug: Neomycin
    Oral three times daily (Days 1-3)
    Other Names:
  • Neo-Fradin
  • Drug: Ciprofloxacin
    Oral twice daily (Days 4-14)
    Other Names:
  • Cipro
  • Drug: Polyethylene Glycol 3350
    Dissolved in Gatorade on day 2
    Other Names:
  • Miralax
  • Drug: Fluconazole
    Orally once daily (Day 1-14)
    Other Names:
  • Diflucan
  • Placebo Comparator: Group 1-Placebo

    Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo.

    Drug: Vancomycin
    Oral suspension 4 times daily (Day 1-14)
    Other Names:
  • Vancocin
  • Drug: Neomycin
    Oral three times daily (Days 1-3)
    Other Names:
  • Neo-Fradin
  • Drug: Ciprofloxacin
    Oral twice daily (Days 4-14)
    Other Names:
  • Cipro
  • Drug: Polyethylene Glycol 3350
    Dissolved in Gatorade on day 2
    Other Names:
  • Miralax
  • No Intervention: Group 2

    Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.

    Outcome Measures

    Primary Outcome Measures

    1. Change in FCP in Group 2 Participants [change from baseline to day 12]

      Change in fecal calprotectin between stool samples collected at baseline and day 12 after procedure in Group 2 participants.

    2. Change in Disease Activity by Pediatric Crohn's Disease Activity Index [Baseline, Day 15]

      The primary endpoint will be the change in disease activity, as measured by Pediatric Crohn's Disease Activity Index (PCDAI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The Pediatric Crohn's Disease Activity Index is a clinical score which takes into account general well being, degree of abdominal pain, number of liquid stools per day, abdominal physical examination, and Crohn's disease complications.

    3. Change in Disease Activity by Fecal Calprotectin (FCP) [Baseline, Day 15]

      The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.

    Secondary Outcome Measures

    1. Change in C-reactive Protein (CRP) [Baseline, Day 15]

      A secondary outcome measure will be the change in C-reactive protein between the enrollment visit and day 15. The C-reactive protein is a blood test which measures systemic inflammation.

    2. Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events [105 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Group 1

    Inclusion Criteria:
    • Males or females 6-18 years of age

    • Current weight >10 kg (or 22 lb)

    • Ability to swallow pills

    • Normal kidney function

    • Normal Aspartate transaminase (AST), Alanine transaminase (ALT), and alkaline phosphatase

    • Active CD or IBDU defined as PCDAI ≥ 30

    • C-Reactive Protein (CRP) ≥ 15mg/L (or 1.5mg/dL) or fecal calprotectin (FCP)>350mcg/g (within one month of enrollment)

    • Have been treated with one of the following therapies for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages.

    Exclusion Criteria:
    • Known allergy or intolerance to aminoglycosides or any of the medications used in this study

    • Current use of one or more of the following medications: 5-fluorouracil, digoxin, anticoagulants, theophylline, phenytoin, probenecid, duloxetine, clozapine, sildenafil, hydrochlorothiazide, cyclosporine, hypoglycemics, terfenadine, tacrolimus, rifabutin, midazolam, and voriconazole

    • Known diagnosis of diabetes mellitus

    • Known or suspected structuring disease producing obstructive symptoms

    • Active Clostridium difficile infection

    • Prolonged QTc interval as seen on enrollment EKG

    • Current use of antibiotics

    • Starting or increasing the dose of an IBD related medication within 4 weeks of screening

    Group 2

    Inclusion Criteria

    • Males or females 10 years of age and older.

    • Patients undergoing a clinical GI endoscopy due to suspicion for active intestinal inflammation determined by physician global assessment (PGA).

    • Undergoing a bowel preparation as part of clinical care.

    • Parental/guardian permission (informed consent) and if appropriate, child assent.

    Exclusion Criteria

    • Antibiotic use within the past 30 days.

    • Current presence of an ostomy bag.

    • Patients undergoing a non- polyethylene glycol 3350 cleanout.

    • Unwillingness to provide informed consent.

    • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19146

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia
    • University of Pennsylvania
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Lindsey Albenberg, DO, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital of Philadelphia
    ClinicalTrials.gov Identifier:
    NCT03476317
    Other Study ID Numbers:
    • 17-014343
    • 5K23DK109136-02
    First Posted:
    Mar 26, 2018
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    Period Title: Overall Study
    STARTED 0 0 10
    COMPLETED 0 0 10
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2 Total
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin. Total of all reporting groups
    Overall Participants 0 0 10 10
    Age (Count of Participants)
    <=18 years
    9
    Infinity
    9
    Infinity
    Between 18 and 65 years
    1
    Infinity
    1
    Infinity
    >=65 years
    0
    NaN
    0
    NaN
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    16.5
    16.5
    Sex: Female, Male (Count of Participants)
    Female
    2
    Infinity
    2
    Infinity
    Male
    8
    Infinity
    8
    Infinity
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    NaN
    Region of Enrollment (participants) [Number]
    United States
    10
    Infinity
    10
    Infinity
    Calprotectin (mcg/g) [Median (Full Range) ]
    Median (Full Range) [mcg/g]
    1254.5
    1254.5

    Outcome Measures

    1. Primary Outcome
    Title Change in FCP in Group 2 Participants
    Description Change in fecal calprotectin between stool samples collected at baseline and day 12 after procedure in Group 2 participants.
    Time Frame change from baseline to day 12

    Outcome Measure Data

    Analysis Population Description
    Group 1 study was not done.
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    Measure Participants 0 0 10
    Median (Full Range) [mcg/g]
    1501
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Group 2
    Comments
    Type of Statistical Test Equivalence
    Comments Median difference in calprotectin for controls from day 12 to baseline
    Statistical Test of Hypothesis p-Value 1.0
    Comments
    Method Wilcoxon (Mann-Whitney)
    Comments
    2. Primary Outcome
    Title Change in Disease Activity by Pediatric Crohn's Disease Activity Index
    Description The primary endpoint will be the change in disease activity, as measured by Pediatric Crohn's Disease Activity Index (PCDAI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The Pediatric Crohn's Disease Activity Index is a clinical score which takes into account general well being, degree of abdominal pain, number of liquid stools per day, abdominal physical examination, and Crohn's disease complications.
    Time Frame Baseline, Day 15

    Outcome Measure Data

    Analysis Population Description
    This outcome was specific to Group 1 and we did not enroll patients into Group1as an identical study was simultaneously enrolling adult patients and results from the adult study were sufficient to make a conclusion without enrolling children.
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    Measure Participants 0 0 0
    3. Primary Outcome
    Title Change in Disease Activity by Fecal Calprotectin (FCP)
    Description The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.
    Time Frame Baseline, Day 15

    Outcome Measure Data

    Analysis Population Description
    This outcome was specific to Group 1 and Group 1 study was not completed.
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    Measure Participants 0 0 0
    4. Secondary Outcome
    Title Change in C-reactive Protein (CRP)
    Description A secondary outcome measure will be the change in C-reactive protein between the enrollment visit and day 15. The C-reactive protein is a blood test which measures systemic inflammation.
    Time Frame Baseline, Day 15

    Outcome Measure Data

    Analysis Population Description
    This outcome was specific to Group 1 and Group 1 study was not completed.
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    Measure Participants 0 0 0
    5. Secondary Outcome
    Title Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events
    Description
    Time Frame 105 days

    Outcome Measure Data

    Analysis Population Description
    This outcome is specific to Group 1 and Group 1 study was not completed.
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    Measure Participants 0 0 0

    Adverse Events

    Time Frame 14 days
    Adverse Event Reporting Description Group 1 study was not completed
    Arm/Group Title Group 1-Fluconazole Group 1-Placebo Group 2
    Arm/Group Description Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
    All Cause Mortality
    Group 1-Fluconazole Group 1-Placebo Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/10 (0%)
    Serious Adverse Events
    Group 1-Fluconazole Group 1-Placebo Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    Group 1-Fluconazole Group 1-Placebo Group 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/10 (0%)

    Limitations/Caveats

    Group 1 study was not completed.

    More Information

    Certain Agreements

    All Principal Investigators ARE 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

    Name/Title Lindsey Albenberg, DO
    Organization Children's Hospital of Philadelphia
    Phone 267-426-0139
    Email albenbergl@chop.edu
    Responsible Party:
    Children's Hospital of Philadelphia
    ClinicalTrials.gov Identifier:
    NCT03476317
    Other Study ID Numbers:
    • 17-014343
    • 5K23DK109136-02
    First Posted:
    Mar 26, 2018
    Last Update Posted:
    Feb 9, 2022
    Last Verified:
    Feb 1, 2022