Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease



Status:Recruiting
Conditions:Colitis, Colitis, Irritable Bowel Syndrome (IBS), Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:7 - 18
Updated:3/23/2019
Start Date:April 10, 2018
End Date:December 2, 2020
Contact:Heather C Kaplan, MD
Email:Heather.Kaplan@CCHMC.org
Phone:513-803-0478

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Using Single Subject (N-of-1) Designs to Answer Patient-Identified Research Questions--Aim 1: Personalized Research on Diet in Ulcerative Colitis and Crohn's Disease

A series of N-of-1 trials will be used to determine the effectiveness of a specific
carbohydrate diet (SCD) versus a modified SCD in patients in reducing symptoms and
inflammatory burden at both the individual and population level. This is a four-year study.
The study staff will recruit 50 patients across up to 21 sites in patients aged 7-18 with
mild to moderate disease activity.


Inclusion Criteria:

- Diagnosis of Crohn's Disease (CD) or ulcerative colitis (UC) or Indeterminate colitis
(IC)

- Age 7-18 years

- Enrolled in the ImproveCareNow (ICN2) registry

- Evidence of acute inflammation and/or elevated acute phase reactant as measured by
Fecal calprotectin 1.5 times the upper limit of normal, Lactoferrin 1.5 times the
upper limit of normal, CRP 1.15 times the upper limit of normal, or ESR 1.15 times the
upper limit of normal (based on local reference ranges) obtained within 8 weeks of
enrollment.

- Potential participants who are close to meeting one of the acute inflammation
and/or elevated acute phase reactant markers and who meet all other study
criteria will be considered for study participation on a case by case basis by
the investigative study team in consultation with the patient's primary
gastroenterologist.

Exclusion Criteria:

Complex and Unstable IBD:

- Currently or within the past 9 months has had an intra-abdominal abscess, fistula,
stricturing CD, or ostomy

- Severe disease activity as measured by a short Pediatric Crohn's Disease Activity
Index (SPCDAI) score of >45 or Pediatric Ulcerative Colitis Activity Index (PUCAI)
score of >60 assessed within three weeks of enrollment

- Ever had history of full colectomy

- Hospitalization or surgery planned within 3 months

- Ongoing active gastrointestinal infection

- Severe Malnutrition (BMI less than 5th percentile)

- Recent medication changes including:

- Thiopurines, natalizumab, or methotrexate started within 8 weeks prior to
enrollment

- Anti TNF (infliximab, adalimumab) started within 8 weeks prior to enrollment

- Vedolizumab started within 16 weeks prior to enrollment

- Increase in corticosteroids within 4 weeks of screening or have dose >20 mg
prednisone or equivalent

Evidence of Other Complicating Medical Issues:

- Other serious medical conditions, such as neurological, liver, kidney, or systemic
disease

- Serious psychological or psychiatric conditions such as eating disorders or self-harm

- Pregnancy

- Tobacco, alcohol, or illicit drug abuse

Inability to Complete the Protocol

- Non-English speaking participants

- On SCD or modified SCD anytime within 8 weeks of enrollment

- If an otherwise eligible patient is on SCD or modified SCD within 8 weeks of
enrollment but they are noncompliant per the determination of the patient's
dietitian/primary gastroenterologist, then this patient is eligible to
participant in the study.

- Participants on a vegan diet

- Lack of smart phone and data plan for participating caregiver

- Participating in another concurrent intervention study
We found this trial at
21
sites
3023 Hamaker Court
Fairfax, Virginia 22031
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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993 Johnson Ferry Road Northeast
Atlanta, Georgia 30342
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Charlotte, North Carolina 28204
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5323 Harry Hines Boulevard
Dallas, Texas 75235
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Jacksonville, Florida 32207
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Oakland, California 94609
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13535 Nemours Parkway
Orlando, Florida 32827
(407) 567-4000
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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Palo Alto, California 94304
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Portland, Oregon 97227
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1975 4th Street
San Francisco, California 94158
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Seattle, Washington 98115
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Washington, District of Columbia 20010
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