Ulcerative Colitis
Conditions
Keywords
relapse, carrageenan, inflammation
Brief summary
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.
Detailed description
This study will evaluate the interval to relapse in patients with ulcerative colitis. The patients will be adults, who have been in remission for at least one month. They will have previously required corticosteroids to induce remission. Subjects will be instructed in a no-carrageenan diet and required to follow this diet for the duration of their participation in the clinical study. They will be randomized to receive either placebo capsules or capsules containing carrageenan 100 mg. In this way, the study will be a double blind study of no-carrageenan vs. carrageenan. Main study outcome is the interval to relapse. Since ulcerative colitis is associated with relapses, relapse is anticipated. Other outcome measures will include scores on questionnaires, including the SSCAI and the SIDBQ, and laboratory measurements of inflammation. Subjects will participate for one year or until relapse, with study visits every three months and telephone contacts every two weeks. After three months, participants will increase to two capsules daily, of either placebo or carrageenan.
Interventions
DIETARY_SUPPLEMENTcarrageenan
The intervention is the carrageenan-free diet. Supplementary carrageenan capsules will be given to mimic the carrageenan in the normal diet.
OTHERdietary intervention with no-carrageenan diet
The intervention will consist of the no-carrageenan diet.
Sponsors
The Broad Foundation
University of Chicago
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ulcerative colitis * Adult * In remission * Required corticosteroids to induce remission * Able to make food choices and follow diet
Exclusion criteria
* Not able to make food choices
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Relapses by Group | up to one year of participation for each enrolled subject | log-rank test to test for difference in number of relapses by group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal Calprotectin (Microgram/Gram Stool) | one year or relapse or withdrawal compared with baseline | paired t-test comparing mean values at baseline and at end of study participation by group |
| Serum Interleukin-6 (pg/ml) | change in IL-6 between baseline and up to one year of study participation | Difference in IL-6 between groups between baseline and end of study participation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 5 |
| Total | 12 |
Baseline characteristics
| Characteristic | Carrageenan-free Diet With Placebo | Total | Carrageenan-free Diet w/ Carrageenan |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 12 Participants | 5 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 5 | 51 years STANDARD_DEVIATION 5 | 54 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 12 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 7 participants | 12 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 |
Outcome results
Primary
Number of Relapses by Group
log-rank test to test for difference in number of relapses by group
Time frame: up to one year of participation for each enrolled subject
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carrageenan-free Diet With Placebo | Number of Relapses by Group | 0 relapses |
| Carrageenan-free Diet w/ Carrageenan | Number of Relapses by Group | 3 relapses |
Comparison: Kaplan-Meier life table analysis was performed to compare the two groups. The null hypothesis was that there would be no difference in relapses between the two groups during the study.p-value: 0.046Log Rank
Secondary
Fecal Calprotectin (Microgram/Gram Stool)
paired t-test comparing mean values at baseline and at end of study participation by group
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carrageenan-free Diet With Placebo | Fecal Calprotectin (Microgram/Gram Stool) | -18.4 micrograms/gm stool | Standard Deviation 170 |
| Carrageenan-free Diet w/ Carrageenan | Fecal Calprotectin (Microgram/Gram Stool) | 37.8 micrograms/gm stool | Standard Deviation 33 |
p-value: 0.06t-test, 2 sided
Secondary
Serum Interleukin-6 (pg/ml)
Difference in IL-6 between groups between baseline and end of study participation
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carrageenan-free Diet With Placebo | Serum Interleukin-6 (pg/ml) | -1.11 pg/ml | Standard Deviation 2.22 |
| Carrageenan-free Diet w/ Carrageenan | Serum Interleukin-6 (pg/ml) | 2.44 pg/ml | Standard Deviation 1.49 |
Comparison: paired t-test comparing baseline and value at end of participationp-value: 0.02t-test, 2 sided