Reduced Sulfur Diet in Ulcerative Colitis Patients

NCT04474561 | Completed DMC

• 1 other identifier: REB16-2491
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

A)Background: Approximately 44% of patients with Inflammatory bowel disease have Ulcerative colitis(UC) which is a lifelong, chronic disease, starting in early adulthood, where the colon becomes inflamed and ulcerated due to a complex interaction between genetics, altered immune function, and environmental factors2such as dietary intake. While the etiology of UC is not clear, it is hypothesized the abnormal immune response and chronic inflammation may be caused by dysbiosis of the intestinal microbiota and decreased epithelial barrier function. Substantial evidence suggests that higher than normal levels of hydrogen sulfide (H2S) in the colon plays a role in the etiology of UC. The higher levels of H2S and sulfate-reducing bacteria (SRB) found in the feces of patients with UC is likely caused by the reduced conversion of H2S to thiosulfate by rhodanese (thiosulfate transferase enzyme)12, and increased colonization or activity of SRB. For example, SRB has been identified as the predominant bacterial group in patients with UC compared to the minority group in healthy individuals, and SRB growth is stimulated by the presence of sulfur-rich amino acids. Dietary intervention may help to repair the dysbiosis existing in the microbiome of the patient with UC, but research about food and recurrence of UC is conflicting. Dietary components such as sulfur and sulfates also appear to play a role in the recurrence of UC; although a recent review of the relationship between sulfur-containing foods and UC calls for more randomized controlled trials (RCTs) examining a reduced sulfur diet in UC. With the body of evidence described above, there is a compelling reason to consider that sulfur and sulfate-containing foods contribute to developing severe UC. Thus, understanding how dietary modulation of sulfur intake within the context of UC impacts disease status is the focus of this proposal.

Conditions

Ulcerative Colitis; Diet Habit

Outcome Measures

Primary Outcomes (1)

• Mayo Score: Change is being assessed

  Mayo score is used for patients with active disease.Mayo Score is one of the most commonly used indices of UC severity. Score ranges from 0-12 with a score ≤ 2.5 indicating remission. Mayo Score includes ratings of stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. Higher score means worse outcomes. For the patients in remission disease activity will be measured using the non-invasive partial Mayo Score calculated at baseline and week 8. Partial Mayo score excludes mucosal appearance at endoscopy but includes stool frequency, rectal bleeding, and physician rating of disease .

  Baseline and week -8

Secondary Outcomes (9)

• Fecal sulfate: Change is being assessed

  Baseline, week-8

• Urinary sulfate: Change is being assessed

  Baseline, Week -8

• Stool microbiome: Change is being assessed

  Baseline, Week-8

• Serum metabolomics: Change is being assessed

  Baseline, Week-8

• Health related quality of life: Change is being assessed

  Baseline, Week-8

Study Arms (2)

Reduced sulfur diet intervention (INT)

OTHER

The INT group will receive conventional management plus a reduced sulfur diet and diet counselling by an RD. Implementation of the diet will be delivered directly by the RD and will provide each patient with an individualized plan. A reduced sulfur diet includes reducing foods, additives and beverages high in sulfate/sulfur. The reduced sulfur diet eating plan, resources on reduced sulfur eating, and RD counselling session will be designed and reviewed by experts in nutrition, dietary design, education resources and dietary behaviour change

Other: Reduced sulfur diet

Conventional management (CM)

NO INTERVENTION

The CM group will receive one session with RD on reduced sulfur diet at the end of 8 weeks.CM groups will receive conventional management .

Interventions

Reduced sulfur diet OTHER

A reduced sulfur diet includes reducing foods, food additives (e.g., carrageenan) and beverages high in sulfate/sulfur, limiting sulfur containing supplements, and consuming omega-3 fatty acid supplements to potentially help control overgrowth of sulfur-reducing bacteria in the colon. Omega-3 fatty acid intake for cardiovascular disease prevention should be around 500 mg/d23. After dietary assessment if patients are not meeting their required daily intake of 500 mg/d of Omega-3, the RD will recommend increased fish consumption to 200 g per week or 1 g/d of an Omega-3 supplement. This will ensure the daily recommended intake of 500 mg/d is being met to reduce the chances of a deficiency; however, a therapeutic dose for UC will not be recommended (i.e., \> 4 g/d18).

Reduced sulfur diet intervention (INT)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years.
• Currently experiencing a mild or moderate UC flare managed with either ≥1.2 grams of oral 5-ASA, topical 5-ASA, combination oral and topical 5-ASA with or without oral corticosteroid therapy or UC in remission, define by partial Mayo score \< 3, treated with any 5-ASA preparation, or biologic therapies
• Ability to provide informed consent and willingness to undergo 2 endoscopic assessments if flare.

You may not qualify if:

• Experiencing a severe UC flare.
• Have any other major medical comorbidities (diabetes, active malignancy within the past 5 years, active infections, severe respiratory or cardiac disease, or acute or chronic kidney disease).
• Have a history of previous bowel surgery.
• Smokers.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

TRW building, Foothills, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Related Publications (1)

• Strauss JC, Haskey N, Ramay HR, Ghosh TS, Taylor LM, Yousuf M, Ohland C, McCoy KD, Ingram RJM, Ghosh S, Panaccione R, Raman M. Weighted Gene Co-Expression Network Analysis Identifies a Functional Guild and Metabolite Cluster Mediating the Relationship between Mucosal Inflammation and Adherence to the Mediterranean Diet in Ulcerative Colitis. Int J Mol Sci. 2023 Apr 15;24(8):7323. doi: 10.3390/ijms24087323.

  PMID: 37108484 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Feeding Behavior

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Director Clinician Investigator Program (CIP), Medical Director Alberta's Collaboration of Excellence for Nutrition in Digestive Diseases (Ascend) , Medical Director Nutrition Services

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 17, 2020
• Study Start: April 20, 2016
• Primary Completion: January 30, 2021
• Study Completion: March 30, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

CA (1)