Trial Outcomes & Findings for Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease (NCT NCT03058679)

NCT ID: NCT03058679

Last Updated: 2021-07-21

Results Overview

Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI \<150 in the absence of initiation or increase of any CD medications

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 197 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2021-07-21

Participant Flow

The study was conducted in 33 clinical sites across the United States. Enrollment in the trial occurred between September 29, 2017 and October 8, 2019.

There were 3 main reasons that participants who consented to the study were not randomized. The majority did not meet eligibility criteria. A small number withdrew or were lost to follow-up

Participant milestones

Measure	Specific Carbohydrate Diet Diet: food for the diet will be provided to the participants for 6 weeks	Mediterranean Style Diet Diet: food for the diet will be provided to the participants for 6 weeks
Baseline to Week 6 STARTED	99	92
Baseline to Week 6 COMPLETED	81	77
Baseline to Week 6 NOT COMPLETED	18	15
Week 6 to Week 12 STARTED	81	77
Week 6 to Week 12 COMPLETED	61	60
Week 6 to Week 12 NOT COMPLETED	20	17

Reasons for withdrawal

Measure	Specific Carbohydrate Diet Diet: food for the diet will be provided to the participants for 6 weeks	Mediterranean Style Diet Diet: food for the diet will be provided to the participants for 6 weeks
Baseline to Week 6 Lost to Follow-up	3	2
Baseline to Week 6 Change in Crohn's disease medication	4	2
Baseline to Week 6 Adverse Event	6	6
Baseline to Week 6 Withdrawal by Subject	4	3
Baseline to Week 6 Difficulty following the diet	0	2
Baseline to Week 6 Physician Decision	1	0
Week 6 to Week 12 Change in medication	5	7
Week 6 to Week 12 Adverse Event	4	3
Week 6 to Week 12 Withdrawal by Subject	9	4
Week 6 to Week 12 Difficulty following the assigned diet	2	3

Baseline Characteristics

Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

Baseline characteristics by cohort

Measure	Mediterranean Style Diet n=92 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=99 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Total n=191 Participants Total of all reporting groups
Age, Continuous	37.0 years n=5 Participants	36.0 years n=7 Participants	37 years n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	58 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	41 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	92 Participants n=7 Participants	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	86 Participants n=5 Participants	88 Participants n=7 Participants	174 Participants n=5 Participants
Body Mass Index (BMI)	25.1 kg/m2 n=5 Participants	25.6 kg/m2 n=7 Participants	25.3 kg/m2 n=5 Participants
Smoking status Never	68 Participants n=5 Participants	79 Participants n=7 Participants	147 Participants n=5 Participants
Smoking status Past	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Smoking status Current	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Years since CD diagnosis	10 years n=5 Participants	10 years n=7 Participants	10 years n=5 Participants
CD behavior Non-stricturing, nonpenetrating	56 Participants n=5 Participants	60 Participants n=7 Participants	116 Participants n=5 Participants
CD behavior Stricturing	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
CD behavior Penetrating	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
CD behavior Stricturing and penetrating	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Crohn's disease distribution Ileum alone	22 Participants n=5 Participants	30 Participants n=7 Participants	52 Participants n=5 Participants
Crohn's disease distribution Colon alone	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Crohn's disease distribution Ileum and Colon	53 Participants n=5 Participants	55 Participants n=7 Participants	108 Participants n=5 Participants
Crohn's disease distribution Missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
History of perianal fistula	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
History of intestinal surgery	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Current use of any biologic	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Current use of immunomodulators	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Current use of oral 5-ASA	6 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants
Current use of rectal 5 ASA	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Current use of oral steroids	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Current use of rectal steroids	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Number of prior anti-TNF medications 0	28 Participants n=5 Participants	34 Participants n=7 Participants	62 Participants n=5 Participants
Number of prior anti-TNF medications 1	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Number of prior anti-TNF medications 2	32 Participants n=5 Participants	26 Participants n=7 Participants	58 Participants n=5 Participants
Number of prior anti-TNF medications 3	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Number of prior anti-TNF medications 4	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Prior ustekinumab	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Prior vedolizumab	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
hsCRP mg/L	2.5 mg/L n=5 Participants	3.2 mg/L n=7 Participants	2.9 mg/L n=5 Participants
hsCRP >5 mg/L	28 Participants n=5 Participants	37 Participants n=7 Participants	65 Participants n=5 Participants
fecal calprotectin (FC) ug/g	40.0 ug/g n=5 Participants	107.5 ug/g n=7 Participants	70 ug/g n=5 Participants
fecal calprotectin (FC) >250 ug/g	13 Participants n=5 Participants	23 Participants n=7 Participants	36 Participants n=5 Participants
Inflammation on colonoscopy Not performed	80 Participants n=5 Participants	89 Participants n=7 Participants	169 Participants n=5 Participants
Inflammation on colonoscopy Yes	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Inflammation on colonoscopy Probably	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Inflammation on colonoscopy Probably not	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Inflammation on colonoscopy No	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
FC>250 ug/g or hsCRP>5 mg/L or definite inflammation on colonoscopy	38 Participants n=5 Participants	50 Participants n=7 Participants	88 Participants n=5 Participants
sCDAI (median, Q1-Q3)	217.7 units on a scale n=5 Participants	226.0 units on a scale n=7 Participants	223.0 units on a scale n=5 Participants
CDAI (median, Q1-Q3)	206.8 units on a scale n=5 Participants	210.0 units on a scale n=7 Participants	209.5 units on a scale n=5 Participants
Short IBDQ (median, Q1-Q3)	38.0 units on a scale n=5 Participants	40.0 units on a scale n=7 Participants	39.0 units on a scale n=5 Participants
PROMIS measures (median, Q1-Q3) Fatigue	60.4 units on a scale n=5 Participants	58.9 units on a scale n=7 Participants	59.6 units on a scale n=5 Participants
PROMIS measures (median, Q1-Q3) Pain interference	60.1 units on a scale n=5 Participants	61.3 units on a scale n=7 Participants	61.2 units on a scale n=5 Participants
PROMIS measures (median, Q1-Q3) Sleep disturbance	57.3 units on a scale n=5 Participants	54.5 units on a scale n=7 Participants	56.0 units on a scale n=5 Participants
PROMIS measures (median, Q1-Q3) Social isolation	48.4 units on a scale n=5 Participants	47.2 units on a scale n=7 Participants	47.9 units on a scale n=5 Participants
Inflammatory back pain screen 0	30 Participants n=5 Participants	40 Participants n=7 Participants	70 Participants n=5 Participants
Inflammatory back pain screen 1-3	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Inflammatory back pain screen >3	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Inflammatory back pain screen Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
AMeD Score	3.0 units on a scale n=5 Participants	2.0 units on a scale n=7 Participants	3.0 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: percentage of participants who achieved symptomatic remission at week 6

Assessed by Short Crohn's Disease Activity Index (sCDAI) - diarrhea, abdominal pain and general well being; sCDAI <150 in the absence of initiation or increase of any CD medications

Outcome measures

Measure	Mediterranean Style Diet n=92 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=99 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Percentage of Participants That Achieved Symptomatic Remission at Week 6	40 Participants	46 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: This measure includes only those whose screening fecal calprotectin (FC) was greater than 250μg/g at baseline and who had an FC results at both baseline and week 6

reduction of calprotectin to less than 250 μg/g and by greater than 50% from screening among those with screening FC >250 μg/g

Outcome measures

Measure	Mediterranean Style Diet n=13 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=23 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Reduction in Bowel Inflammation Among Those Whose Screening Fecal Calprotectin (FC) Was Greater Than 250μg/g at Baseline and Who Had an FC Results at Both Baseline and Week 6	4 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 weeks

Assessed by the CDAI - CDAI <150

Outcome measures

Measure	Mediterranean Style Diet n=92 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=99 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Percentage of Participants That Reached Clinical Remission at Week 6	44 Participants	48 Participants

SECONDARY outcome

Timeframe: 6 weeks

Population: This measure includes only those that had a screening hsCRP \> 5mg/L and had hsCRP measured at both screening and at week 6

reduction in high-sensitivity CRP (hsCRP) to <5 mg/L and >50% reduction from screening among those with screening hsCRP >5mg/L

Outcome measures

Measure	Mediterranean Style Diet n=28 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=37 Participants Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Percentage of Participants With a Reduction in Systemic Inflammation at Week 6	1 Participants	2 Participants

Adverse Events

Mediterranean Style Diet

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

Specific Carbohydrate Diet

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mediterranean Style Diet n=92 participants at risk Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=99 participants at risk Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Gastrointestinal disorders Small intestinal obstruction	1.1% 1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	1.0% 1/99 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Abdominal pain	3.3% 3/92 • Number of events 3 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	1.0% 1/99 • Number of events 3 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Worsening of Crohn's disease	0.00% 0/92 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	2.0% 2/99 • Number of events 2 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Rectal hemorrhage	1.1% 1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	0.00% 0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Diarrhea	1.1% 1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	0.00% 0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Nausea	1.1% 1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	0.00% 0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Vomiting	1.1% 1/92 • Number of events 1 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	0.00% 0/99 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).

Other adverse events

Measure	Mediterranean Style Diet n=92 participants at risk Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks	Specific Carbohydrate Diet n=99 participants at risk Diet: food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
Gastrointestinal disorders Abdominal pain	14.1% 13/92 • Number of events 14 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	10.1% 10/99 • Number of events 11 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Diarrhea	7.6% 7/92 • Number of events 7 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	5.1% 5/99 • Number of events 5 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).
Gastrointestinal disorders Gastrointestingal disorders other - Worsening of Crohn's disease symptons	4.3% 4/92 • Number of events 4 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).	6.1% 6/99 • Number of events 7 • AEs were recorded at each study contact from screening visit to a participant's end of study visit. For participants that completed the study, AEs were assessed at screening, baseline, wk 6 and week 12. Among participants who withdrew early from the study, AEs were assessed at the above named timepoints until the time of withdraw. The clinical course of each AE was followed until resolution, stabilization, or until it was determined that study intervention or participation was not the cause. As per the DINE-CD protocol, allergic reaction to a component of the food, intolerance of the food other than allergic reaction, worsening of CD and worsening of extraintestinal manifestations of CD was considered expected. AEs were included for all randomized participants who started the diet with the exception of 3 participant who were randomized in error with an sCDAI \<150 (as noted in the participant flow).

Additional Information

Dr. James D. Lewis

University of Pennsylvania

Phone: 215-573-5137

Email: lewisjd@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place