Ulcerative Colitis
Conditions
Brief summary
This study tests the hypothesis that a supplement that combines a functional fiber, long chain omega-3 polyunsaturated fatty acids (PUFAs), vitamin D3, vitamin E, and zinc will reduce clinical symptoms, decrease pro-inflammatory cytokines in the blood and ergo decrease inflammation, promote beneficial microbial activity in the colon, and help recovery of the intestinal mucosa of ulcerative colitis (UC) patients compared with a placebo.
Detailed description
An anticipated 30 participants with newly diagnosed active ulcerative colitis will be recruited to participate in a randomized control trial, with 50% of the subjects distributed to the supplement (n=15) and the other 50% provided a placebo control (n=15). This is considered as a proof of concept study to determine if there is evidence that a multi-ingredient supplement (immunonutrition) will reduce UC disease severity.
Interventions
DIETARY_SUPPLEMENTNutrition supplement
Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc
DIETARY_SUPPLEMENTPlacebo supplement
rice starch, light olive oil, vegetable oil
Sponsors
Baptist Memorial Health Care Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with active ulcerative colitis (proof of diagnosis from gastroenterologist), over 18 years old, has over 50% gut remaining, fully connected bowels (no colostomy), currently on 5-aminosalicylates (ASA) drugs, not pregnant or lactating
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduced inflammatory cytokines | 2 months | cytokines will be isolated from blood analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts | 2 months | SCFA will be isolated from stool sample. SCFAs are anti-inflammatory components generated in the colon. The SCFAs looked at include acetate, lactate, propionate, butyrate, and isobutyrate. |
| Reduced bowel movements per day | 2 months | Many with Ulcerative colitis can experience 10+ bowel movements per day. This intervention is aiming to reduce the total number of bowel movements per day |
| Decreased intestinal cramping/ pain | 2 months | Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants |
Countries
United States
Contacts
Primary ContactKatie E Cook, BA
Backup ContactRandal K Buddington, PhD
Outcome results
None listed