Trial Outcomes & Findings for Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity (NCT NCT01065571)

NCT ID: NCT01065571

Last Updated: 2019-11-26

Results Overview

log-rank test to test for difference in number of relapses by group

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: up to one year of participation for each enrolled subject
• Results posted on: 2019-11-26

Participant Flow

Participant milestones

Measure	Carrageenan-free Diet With Placebo This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet.	Carrageenan-free Diet w/ Carrageenan The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
Overall Study STARTED	10	5
Overall Study COMPLETED	7	5
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity

Baseline characteristics by cohort

Measure	Carrageenan-free Diet With Placebo n=7 Participants This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet.	Carrageenan-free Diet w/ Carrageenan n=5 Participants The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	50 years STANDARD_DEVIATION 5 • n=5 Participants	54 years STANDARD_DEVIATION 5 • n=7 Participants	51 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: up to one year of participation for each enrolled subject

log-rank test to test for difference in number of relapses by group

Outcome measures

Measure	Carrageenan-free Diet With Placebo n=7 Participants This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet.	Carrageenan-free Diet w/ Carrageenan n=5 Participants The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
Number of Relapses by Group	0 relapses	3 relapses

SECONDARY outcome

Timeframe: one year or relapse or withdrawal compared with baseline

Population: participants who had fecal calprotectin tests at baseline and at end of participation at one year or at time of relapse or withdrawal from study participation

paired t-test comparing mean values at baseline and at end of study participation by group

Outcome measures

Measure	Carrageenan-free Diet With Placebo n=5 Participants This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet.	Carrageenan-free Diet w/ Carrageenan n=5 Participants The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
Fecal Calprotectin (Microgram/Gram Stool)	-18.4 micrograms/gm stool Standard Deviation 170	37.8 micrograms/gm stool Standard Deviation 33

SECONDARY outcome

Timeframe: change in IL-6 between baseline and up to one year of study participation

Population: change in IL-6 between baseline and end of participation

Difference in IL-6 between groups between baseline and end of study participation

Outcome measures

Measure	Carrageenan-free Diet With Placebo n=4 Participants This is the experimental arm in which subjects will be on a no-carrageenan diet and receive placebo capsules. This will test whether the no carrageenan diet leads to longer relapse-free interval for patients with ulcerative colitis. dietary intervention with no-carrageenan diet: The intervention will consist of the no-carrageenan diet.	Carrageenan-free Diet w/ Carrageenan n=5 Participants The carrageenan-free diet with carrageenan supplement will mimic the carrageenan normally consumed in the diet. The study will permit blinded comparison of carrageenan-free vs. carrageenan consumption. carrageenan: The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
Serum Interleukin-6 (pg/ml)	-1.11 pg/ml Standard Deviation 2.22	2.44 pg/ml Standard Deviation 1.49

Adverse Events

Carrageenan-free Diet w/ Carrageenan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carrageenan-free Diet With Placebo

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

Joanne Tobacman, MD

University of Illinois at Chicago

Phone: 312-569-7826

Email: jkt@uic.edu

Results disclosure agreements

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