Ulcerative ColitisNCT03594708
Immunonutrition in Ulcerative Colitis
A study testing Nutrition supplement in people with Ulcerative Colitis, run by Baptist Memorial Health Care Corporation at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Nutrition supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
GI Specialists Foundation
Memphis, Tennessee, 38120
Paul Bierman, MD, 901-761-3900, Paul.Bierman@bmg.md
About this study
Official title: Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Nutrition supplement, Placebo supplement
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition supplementDietary supplement
Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc
Placebo supplementDietary supplement
rice starch, light olive oil, vegetable oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo consisting of rice starch, light olive oil, and vegetable oil Receives: Dietary Supplement: Placebo supplement |
| Supplement | Active comparator | active supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc Receives: Dietary Supplement: Nutrition supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced inflammatory cytokines
cytokines will be isolated from blood analysis
Measured: 2 months
Secondary outcomes (3)
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts
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.
Measured: 2 months
Reduced bowel movements per day
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
Measured: 2 months
Decreased intestinal cramping/ pain
Many with ulcerative colitis experience constant intestinal cramping. This intervention is geared towards reducing pain and discomfort for the participants
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start30 Apr 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baptist Memorial Health Care Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Cook, Baptist Memorial Health Care Corporation
- Investigators
- Randal K Buddington, PhD, Principal investigator, The University of Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594708
- Sponsor's protocol ID
- UCS2018
- Status last verified
- Jul 2018
- First submitted
- 19 Jan 2018
- Last updated
- 20 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torres MI, Rios A. Current view of the immunopathogenesis in inflammatory bowel disease and its implications for therapy. World J Gastroenterol. 2008 Apr 7;14(13):1972-80. doi: 10.3748/wjg.14.1972.
PubMed 18395894Lewis JD, Abreu MT. Diet as a Trigger or Therapy for Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):398-414.e6. doi: 10.1053/j.gastro.2016.10.019. Epub 2016 Oct 25.
PubMed 27793606Ruemmele FM. Role of Diet in Inflammatory Bowel Disease. Ann Nutr Metab. 2016;68 Suppl 1:33-41. doi: 10.1159/000445392. Epub 2016 Jun 30.
PubMed 27355913Rampertab S, Brown A. Inflammatory bowel disease. In: The Health Professional's Guide to Gastrointestinal Nutrition. Academy of Nutrition and Dietetics, 2015.
Seidner DL, Lashner BA, Brzezinski A, Banks PL, Goldblum J, Fiocchi C, Katz J, Lichtenstein GR, Anton PA, Kam LY, Garleb KA, Demichele SJ. An oral supplement enriched with fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis: a randomized, controlled trial. Clin Gastroenterol Hepatol. 2005 Apr;3(4):358-69. doi: 10.1016/s1542-3565(04)00672-x.
PubMed 15822041
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT03594708
- Acronym / sponsor ID
- UCS2018
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Baptist Memorial Health Care CorporationUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementplacebo consisting of rice starch, light olive oil, and vegetable oil |
| Supplement | Active comparator | Dietary Supplement: Nutrition supplementactive supplement consisting of a fermentable fiber, omega-3 polyunsaturated fatty acid, vitamin D3, vitamin E, and zinc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition supplementFermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc | Dietary supplement | Supplement |
| Placebo supplementrice starch, light olive oil, vegetable oil | Dietary supplement | Placebo |
Primary outcome
Reduced inflammatory cytokines
Time frame: 2 months
cytokines will be isolated from blood analysis
3 secondary outcomes
Improved microbiome/ increased Short-Chain Fatty acid (SCFA) counts
Time frame: 2 months
Reduced bowel movements per day
Time frame: 2 months
Decreased intestinal cramping/ pain
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Background: PubMed 18395894Torres MI, Rios A. Current view of the immunopathogenesis in inflammatory bowel disease and its implications for therapy. World J Gastroenterol. 2008 Apr 7;14(13):1972-80. doi: 10.3748/wjg.14.1972.
- Background: PubMed 27793606Lewis JD, Abreu MT. Diet as a Trigger or Therapy for Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):398-414.e6. doi: 10.1053/j.gastro.2016.10.019. Epub 2016 Oct 25.
- Background: PubMed 27355913Ruemmele FM. Role of Diet in Inflammatory Bowel Disease. Ann Nutr Metab. 2016;68 Suppl 1:33-41. doi: 10.1159/000445392. Epub 2016 Jun 30.
- BackgroundRampertab S, Brown A. Inflammatory bowel disease. In: The Health Professional's Guide to Gastrointestinal Nutrition. Academy of Nutrition and Dietetics, 2015.
- Background: PubMed 15822041Seidner DL, Lashner BA, Brzezinski A, Banks PL, Goldblum J, Fiocchi C, Katz J, Lichtenstein GR, Anton PA, Kam LY, Garleb KA, Demichele SJ. An oral supplement enriched with fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis: a randomized, controlled trial. Clin Gastroenterol Hepatol. 2005 Apr;3(4):358-69. doi: 10.1016/s1542-3565(04)00672-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randal K Buddington, PhD principal investigator
The University of Memphis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition supplement in people with Ulcerative Colitis, run by Baptist Memorial Health Care Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katie E Cook, BA (612-804-5322, kecook1@memphis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced inflammatory cytokines (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03594708, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.