N/A
N=15
Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity
Ulcerative Colitis
Bottom Line
View on ClinicalTrials.gov: NCT01065571 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Number of Relapses by Group — 0; 3 relapses — p=0.046
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- carrageenan (Dietary_supplement); dietary intervention with no-carrageenan diet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Relapses by Group |
0; 3 | 0.046 sig |
| SECONDARY Fecal Calprotectin (Microgram/Gram Stool) |
-18.4; 37.8 | 0.06 |
| SECONDARY Serum Interleukin-6 (pg/ml) |
-1.11; 2.44 | 0.02 sig |
Summary
The study hypothesis is that withdrawal of carrageenan will lead to a longer, relapse free interval in patients with ulcerative colitis.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01065571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.