The Effect of Diet on Disease Activity and Symptoms in Patients With Ulcerative Colitis

NCT03053713 | Completed

• 1 other identifier: H16-03300
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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). Symptoms, blood and stool will be examined to determine if the MDP results in changes to the intestinal bacteria or immune system.

Conditions

Ulcerative Colitis

Keywords

Mediterranean diet pattern; nutrition; diet intervention; disease activity; intestinal microbiome; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline to week 12

Secondary Outcomes (5)

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

  12 weeks

• Fecal microbiota

  12 weeks

• Change in mucosal inflammation measured by fecal calprotectin

  12 weeks

• Change in serum marker of inflammation (serum CRP)

  12 weeks

• Change in serum marker of inflammation (serum ferritin)

  12 weeks

Study Arms (2)

Mediterranean Diet Pattern

ACTIVE COMPARATOR

Mediterranean diet pattern x 12 weeks.

Behavioral: Mediterranean diet pattern

Habitual Diet

PLACEBO COMPARATOR

Habitual diet (control) x 12 weeks.

Behavioral: Habitual diet (control)

Interventions

Mediterranean diet pattern BEHAVIORAL

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.

Mediterranean Diet Pattern

Habitual diet (control) BEHAVIORAL

Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.

Habitual Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Severe psychiatric disorder
• Unable or unwilling to consent
• Unable to comply with study requirements
• Presence of alcohol or drug abuse

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Foundation for Dietetic Research (CFDR): collaborator

Study Sites (1)

University of British Columbia - Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (5)

• 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.

  PMID: 27067195 BACKGROUND

• Strisciuglio 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.

  PMID: 27306105 BACKGROUND

• Marlow 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.

  PMID: 24283712 BACKGROUND

• Haskey 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.

  PMID: 40242173 DERIVED

• Haskey 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.

  PMID: 36618690 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Deanna L Gibson, PhD

  University of British Columbia- Okanagan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: February 15, 2017
• Study Start: April 4, 2017
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)