Trial Outcomes & Findings for Crohn Disease Exclusion Diet After Single Medication De-escalation (NCT NCT02472457)

NCT ID: NCT02472457

Last Updated: 2020-10-20

Results Overview

Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

At 52 weeks following enrollment

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Free Diet No dietary restrictions Free Diet: This diet contains no restrictions.	Crohn Disease Exclusion Diet The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation. Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.
Overall Study STARTED	8	11
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Crohn Disease Exclusion Diet After Single Medication De-escalation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Free Diet n=8 Participants No dietary restrictions Free Diet: This diet contains no restrictions.	Crohn Disease Exclusion Diet n=10 Participants The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation. Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.	Total n=18 Participants Total of all reporting groups
Age, Continuous	16.5 years STANDARD_DEVIATION 3.6 • n=93 Participants	16.0 years STANDARD_DEVIATION 2.2 • n=4 Participants	16.2 years STANDARD_DEVIATION 2.8 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment United States	7 participants n=93 Participants	6 participants n=4 Participants	13 participants n=27 Participants
Region of Enrollment Israel	1 participants n=93 Participants	4 participants n=4 Participants	5 participants n=27 Participants

PRIMARY outcome

Timeframe: At 52 weeks following enrollment

Population: 1 participant in the free diet group followed the specific carbohydrate diet and was in remission at 52 weeks. 1 participant in the CDED group withdrew prior to 52 weeks.

Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

Outcome measures

Outcome measures
Measure	Free Diet n=8 Participants No dietary restrictions Free Diet: This diet contains no restrictions.	Crohn Disease Exclusion Diet n=9 Participants The CDED is a palatable diet that excludes foods suspected to have a role in intestinal inflammation. Crohn Disease Exclusion Diet: The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.
Sustained Relapse-free Remission	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 104 weeks

Remission defined by the Pediatric Crohn Disease Activity Index, C-reactive protein, and stool calprotectin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Change in the microbial composition of the stool, mouth and rectum from baseline to 6 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 52 weeks

Change in the microbial composition of the stool, mouth and rectum from baseline to 52 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 52 weeks

Using modified Medication Adherence Rating Scale (MARS) questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Free Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crohn Disease Exclusion Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ronen Stein, MD

The Children's Hospital of Philadelphia

Phone: 215-590-7801

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place