Ulcerative ColitisNCT03053713
The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis
A study testing Mediterranean diet pattern in people with Ulcerative Colitis, run by University of British Columbia at 1 site in Canada.
Trial summary
The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mediterranean diet pattern
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 4 Apr 2017to 30 Aug 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative Colitis in clinical remission (partial Mayo score 0-1)
- Taking oral 5-ASA, methotrexate, azathioprine or 6-mecaptopurine as long as there have been no changes in dosage for 2 months prior to the start of the study
- Generally healthy besides having UC
- Agree not to use any dietary supplements, herbal treatments, prebiotics, probiotics or diet therapies within three weeks of the onset of the trial or during the study
Who cannot join
- Using prednisone (or steroid equivalent) or biologics (i.e., infliximab, adalimumab, vedolizumab) at the time of enrollment
- Using antibiotics two weeks prior to or anytime during the study period
- Pregnancy, lactation or desire to become pregnant during the study period because we do not know if or how an unborn baby/fetus could be harmed
- History of colectomy or extensive colonic resection or disease is limited to the rectum
- Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen)
- Active gastrointestinal infection (e.g., C. difficile infection)
Show all 10Show fewer
- Severe psychiatric disorder
- Unable or unwilling to consent
- Unable to comply with study requirements
- Presence of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia - Okanagan
Kelowna, British Columbia, V1V 1V7
About this study
Official title: The Effect of Diet Modification on Clinical Disease Activity, the Gut Microbiome and Immune Responses in Patients With Ulcerative Colitis
The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.
Read the detailed description
Few studies have found a single dietary factor as being protective or detrimental against inflammatory bowel disease (IBD), therefore novel diet approaches for the prevention and treatment of IBD are urgently needed. The Mediterranean Diet Pattern (MDP) is associated with improvements in health status and inflammatory markers in healthy individuals and rodent models of colitis. Reductions in inflammatory biomarkers and a "normalization" of the gut microbiota have been shown in patients with Crohn's disease following a MDP. To date, no studies have examined the effect of MDP on disease activity, inflammatory markers or the effects on the microbiome in ulcerative colitis (UC).
This study will examine the effects of a MDP taken by patients with UC on 1) symptoms, clinical and quality of life endpoints and 2) on gut microbiome and fecal immune biomarkers. One hundred subjects and two subjects with UC will be randomly allocated to follow a MDP for 12 weeks or their usual diet (controls). Upon initiation, throughout and completion of each diet, symptoms, clinical and quality of life endpoints will be monitored. Fecal samples will be collected to assess pH, short-chain fatty acid concentrations, bacterial abundance and diversity.
- Conditions
- Ulcerative Colitis
- Being tested
- Mediterranean diet pattern, Habitual diet (control)
- Keywords
- Mediterranean diet pattern, nutrition, diet intervention, disease activity, intestinal microbiome, inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean diet patternBehavioural
Subjects assigned to the Mediterranean diet pattern arm will receive nutrition advice from a Registered Dietitian (RD). The RD will meet with the subjects (in-person) to provide diet education at randomization, week 3 and week 6 of the intervention. Phone and e-mail follow-up will occur at week 2 and week 9 to provide cooking tips, recipes, videos and answer questions.
Habitual diet (control)Behavioural
Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Pattern | Active comparator | Mediterranean diet pattern x 12 weeks. Receives: Behavioral: Mediterranean diet pattern |
| Habitual Diet | Placebo comparator | Habitual diet (control) x 12 weeks. Receives: Behavioral: Habitual diet (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Clinical Colitis Activity Index (SCCAI)
The SCCAI is a symptom-based disease activity index that uses six clinical parameters: daytime and nocturnal bowel frequency, urgency, amount of blood in the stool, well-being and extraintestinal manifestations. A reduction of SCCAI >1.5 is considered clinically significant and SCCAI score of <4 is indicative of remission.
Measured: Change from baseline to week 12
Secondary outcomes (5)
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Quality of life improvement measured at baseline, week 3, week 6, week 9 and 12.
Measured: 12 weeks
Fecal microbiota
Fecal microbiota measured by examining microbial taxa from stool at baseline and 12 weeks
Measured: 12 weeks
Change in mucosal inflammation measured by fecal calprotectin
Change in mucosal inflammation will be measured by fecal calprotectin at baseline and week 12
Measured: 12 weeks
Change in serum marker of inflammation (serum CRP)
Change in markers of inflammation will be measured by serum CRP
Measured: 12 weeks
Change in serum marker of inflammation (serum ferritin)
Change in markers of inflammation will be measured by serum ferritin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start4 Apr 2017
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a randomized, parallel treatment design, the effects of the Mediterranean diet pattern on symptoms, clinical disease activity, gut microbiome and fecal biomarkers in stable UC patients in remission will be examined. Using this design, we will compare the habitual diet (taken as a "control" diet) to the Mediterranean diet pattern taken by UC patients over a 12-week period.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Foundation for Dietetic Research (CFDR)
- Responsible party
- Principal investigator, Deanna Gibson, University of British Columbia
- Investigators
- Deanna L Gibson, PhD, Principal investigator, University of British Columbia- Okanagan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053713
- Sponsor's protocol ID
- H16-03300
- Status last verified
- May 2022
- First submitted
- 6 Feb 2017
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DeCoffe D, Quin C, Gill SK, Tasnim N, Brown K, Godovannyi A, Dai C, Abulizi N, Chan YK, Ghosh S, Gibson DL. Dietary Lipid Type, Rather Than Total Number of Calories, Alters Outcomes of Enteric Infection in Mice. J Infect Dis. 2016 Jun 1;213(11):1846-56. doi: 10.1093/infdis/jiw084. Epub 2016 Apr 10.
PubMed 27067195Strisciuglio C, Giugliano F, Martinelli M, Cenni S, Greco L, Staiano A, Miele E. Impact of Environmental and Familial Factors in a Cohort of Pediatric Patients With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):569-574. doi: 10.1097/MPG.0000000000001297.
PubMed 27306105Marlow G, Ellett S, Ferguson IR, Zhu S, Karunasinghe N, Jesuthasan AC, Han DY, Fraser AG, Ferguson LR. Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients. Hum Genomics. 2013 Nov 27;7(1):24. doi: 10.1186/1479-7364-7-24.
PubMed 24283712Haskey N, Ye J, Josephson J, Raman M, Ghosh S, Gibson DL. Metabolomic Signatures Highlight Fiber-Degrading Bacteroides Species in Mediterranean Diet Response Among Ulcerative Colitis. Gastro Hep Adv. 2024 Dec 31;4(4):100606. doi: 10.1016/j.gastha.2024.100606. eCollection 2025.
PubMed 40242173Haskey N, Shim RCK, Davidson-Hunt A, Ye J, Singh S, Dieleman LA, Jacobson K, Ghosh S, Gibson DL. Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. Front Nutr. 2022 Dec 21;9:1080156. doi: 10.3389/fnut.2022.1080156. eCollection 2022.
PubMed 36618690
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diet Modification on Clinical Disease Activity, the Gut Microbiome and Immune Responses in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03053713
- Acronym / sponsor ID
- H16-03300
- Conditions
- Ulcerative Colitis
- Keywords
- Mediterranean diet pattern, nutrition, diet intervention, disease activity, intestinal microbiome, inflammatory bowel disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Foundation for Dietetic Research (CFDR)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 15 Feb 2017 (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.
The Mediterranean Diet Pattern (MDP) has been shown to have beneficial effects on the intestinal bacteria and the immune system in diseases like cancer and diabetes. The aim of this study is to determine if a MDP will have an impact on symptoms, intestinal bacteria and the immune system in Ulcerative Colitis (UC). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.
Detailed description
Few studies have found a single dietary factor as being protective or detrimental against inflammatory bowel disease (IBD), therefore novel diet approaches for the prevention and treatment of IBD are urgently needed. The Mediterranean Diet Pattern (MDP) is associated with improvements in health status and inflammatory markers in healthy individuals and rodent models of colitis. Reductions in inflammatory biomarkers and a "normalization" of the gut microbiota have been shown in patients with Crohn's disease following a MDP. To date, no studies have examined the effect of MDP on disease activity, inflammatory markers or the effects on the microbiome in ulcerative colitis (UC).
This study will examine the effects of a MDP taken by patients with UC on 1) symptoms, clinical and quality of life endpoints and 2) on gut microbiome and fecal immune biomarkers. One hundred subjects and two subjects with UC will be randomly allocated to follow a MDP for 12 weeks or their usual diet (controls). Upon initiation, throughout and completion of each diet, symptoms, clinical and quality of life endpoints will be monitored. Fecal samples will be collected to assess pH, short-chain fatty acid concentrations, bacterial abundance and diversity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a randomized, parallel treatment design, the effects of the Mediterranean diet pattern on symptoms, clinical disease activity, gut microbiome and fecal biomarkers in stable UC patients in remission will be examined. Using this design, we will compare the habitual diet (taken as a "control" diet) to the Mediterranean diet pattern taken by UC patients over a 12-week period.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Pattern | Active comparator | Behavioral: Mediterranean diet patternMediterranean diet pattern x 12 weeks. |
| Habitual Diet | Placebo comparator | Behavioral: Habitual diet (control)Habitual diet (control) x 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ulcerative Colitis in clinical remission (partial Mayo score 0-1)
- Taking oral 5-ASA, methotrexate, azathioprine or 6-mecaptopurine as long as there have been no changes in dosage for 2 months prior to the start of the study
- Generally healthy besides having UC
- Agree not to use any dietary supplements, herbal treatments, prebiotics, probiotics or diet therapies within three weeks of the onset of the trial or during the study
Key exclusion criteria (10 listed)
- Using prednisone (or steroid equivalent) or biologics (i.e., infliximab, adalimumab, vedolizumab) at the time of enrollment
- Using antibiotics two weeks prior to or anytime during the study period
- Pregnancy, lactation or desire to become pregnant during the study period because we do not know if or how an unborn baby/fetus could be harmed
- History of colectomy or extensive colonic resection or disease is limited to the rectum
- Significant chronic disorders such as severe cardiac disease, significant renal failure, severe pulmonary disease (need for oxygen)
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 |
|---|---|---|
| Mediterranean diet patternSubjects assigned to the Mediterranean diet pattern arm will receive nutrition advice from a Registered Dietitian (RD). The RD will meet with the subjects (in-person) to provide diet education at randomization, week 3 and week 6 of the intervention. Phone and e-mail follow-up will occur at week 2 and week 9 to provide cooking tips, recipes, videos and answer questions. | Behavioural | Mediterranean Diet Pattern |
| Habitual diet (control)Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks. | Behavioural | Habitual Diet |
Primary outcome
Simple Clinical Colitis Activity Index (SCCAI)
Time frame: Change from baseline to week 12
The SCCAI is a symptom-based disease activity index that uses six clinical parameters: daytime and nocturnal bowel frequency, urgency, amount of blood in the stool, well-being and extraintestinal manifestations. A reduction of SCCAI >1.5 is considered clinically significant and SCCAI score of <4 is indicative of remission.
5 secondary outcomes
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Time frame: 12 weeks
Fecal microbiota
Time frame: 12 weeks
Change in mucosal inflammation measured by fecal calprotectin
Time frame: 12 weeks
Change in serum marker of inflammation (serum CRP)
Time frame: 12 weeks
Change in serum marker of inflammation (serum ferritin)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 27067195DeCoffe D, Quin C, Gill SK, Tasnim N, Brown K, Godovannyi A, Dai C, Abulizi N, Chan YK, Ghosh S, Gibson DL. Dietary Lipid Type, Rather Than Total Number of Calories, Alters Outcomes of Enteric Infection in Mice. J Infect Dis. 2016 Jun 1;213(11):1846-56. doi: 10.1093/infdis/jiw084. Epub 2016 Apr 10.
- Background: PubMed 27306105Strisciuglio C, Giugliano F, Martinelli M, Cenni S, Greco L, Staiano A, Miele E. Impact of Environmental and Familial Factors in a Cohort of Pediatric Patients With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):569-574. doi: 10.1097/MPG.0000000000001297.
- Background: PubMed 24283712Marlow G, Ellett S, Ferguson IR, Zhu S, Karunasinghe N, Jesuthasan AC, Han DY, Fraser AG, Ferguson LR. Transcriptomics to study the effect of a Mediterranean-inspired diet on inflammation in Crohn's disease patients. Hum Genomics. 2013 Nov 27;7(1):24. doi: 10.1186/1479-7364-7-24.
- Derived from this study: PubMed 40242173Haskey N, Ye J, Josephson J, Raman M, Ghosh S, Gibson DL. Metabolomic Signatures Highlight Fiber-Degrading Bacteroides Species in Mediterranean Diet Response Among Ulcerative Colitis. Gastro Hep Adv. 2024 Dec 31;4(4):100606. doi: 10.1016/j.gastha.2024.100606. eCollection 2025.
- Derived from this study: PubMed 36618690Haskey N, Shim RCK, Davidson-Hunt A, Ye J, Singh S, Dieleman LA, Jacobson K, Ghosh S, Gibson DL. Dietary adherence to the Mediterranean diet pattern in a randomized clinical trial of patients with quiescent ulcerative colitis. Front Nutr. 2022 Dec 21;9:1080156. doi: 10.3389/fnut.2022.1080156. eCollection 2022.
- 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.
Deanna L Gibson, PhD principal investigator
University of British Columbia- Okanagan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean diet pattern in people with Ulcerative Colitis, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 23 May 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple Clinical Colitis Activity Index (SCCAI) (time frame: Change from baseline to week 12). 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 NCT03053713, 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 23 May 2022.