NCT03508193

Brief Summary

Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease. Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls. The specific aims of this proposal are:

  1. 1.To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease.
  2. 2.To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease.
  3. 3.To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

4.2 years

First QC Date

April 16, 2018

Last Update Submit

November 17, 2022

Conditions

Crohn Disease

Keywords

Exclusive Enteral NutritionNutritionDietInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Fecal calprotectin <250 micrograms/gram

    surrogate marker of intestinal inflammation

    4 weeks

Secondary Outcomes (1)

  • Quality of life as measured by IMPACT III Questionnaire

    4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Whole-foods based smoothie as nutritional therapy

Other: Nutritional therapy

Interventions

Nutritional therapyOTHER

Whole-foods based smoothie designed to emulate formulas used in EEN

Intervention

Eligibility Criteria

Age8 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 8 -21 years old
  • Diagnosis of Crohn's disease within 4 weeks of study entry
  • Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.
  • Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent

You may not qualify if:

  • History of surgery for Crohn's disease
  • Perianal disease as part of Crohn's disease phenotype
  • Prior treatment with EEN or the specific carbohydrate for Crohn's disease
  • Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.)
  • Prior treatment with antibiotics for Crohn's disease
  • Known allergies to any of the food components in the smoothie
  • Admission to hospital due to severity of Crohn's disease and associated symptoms
  • Unwillingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (3)

  • Johnson T, Macdonald S, Hill SM, Thomas A, Murphy MS. Treatment of active Crohn's disease in children using partial enteral nutrition with liquid formula: a randomised controlled trial. Gut. 2006 Mar;55(3):356-61. doi: 10.1136/gut.2004.062554. Epub 2005 Sep 14.

    PMID: 16162683BACKGROUND

  • Lee D, Baldassano RN, Otley AR, Albenberg L, Griffiths AM, Compher C, Chen EZ, Li H, Gilroy E, Nessel L, Grant A, Chehoud C, Bushman FD, Wu GD, Lewis JD. Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease. Inflamm Bowel Dis. 2015 Aug;21(8):1786-93. doi: 10.1097/MIB.0000000000000426.

    PMID: 25970545BACKGROUND

  • Lee D, Braly K, Nuding M, Braly I, Hopp C, Twible H, Pope C, Hayden HS, Hoffman L, Zheng H, Wahbeh G, Suskind DL. Reverse-engineered exclusive enteral nutrition in pediatric Crohn's disease: A pilot trial. J Pediatr Gastroenterol Nutr. 2024 May;78(5):1135-1142. doi: 10.1002/jpn3.12196. Epub 2024 Apr 1.

    PMID: 38558411DERIVED

MeSH Terms

Conditions

Crohn DiseaseInflammatory Bowel Diseases

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Dale Y Lee, MD

    Seattle Children's Hospital and The University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

November 4, 2017

Primary Completion

January 5, 2022

Study Completion

January 5, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Not Discussed

Locations

US(1)