Low Sulfur Diet for Crohn's Disease
Recruiting in Palo Alto (17 mi)
Overseen byAllen Lee, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan
Must not be taking: Antibiotics, Probiotics
Disqualifiers: Total colectomy, Ileostomy, Vegan, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this study is to learn about a low sulfur diet in patients with Crohn's disease. Study participants will be randomized to receive a low sulfur diet or usual diet for 8 weeks. Participants will work with study nutritionists and receive dietary educational materials. Participants will attend 2 in-person visits as well as 6 phone visits during the study. In addition, subjects will undergo testing, including a test to measure rectal sensation, a test to look for small intestinal bacterial overgrowth, and a test to measure leaky gut.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have changed immunosuppressive medications or used antibiotics or probiotics in the past 4 weeks before joining.
What data supports the effectiveness of the Low Sulfur Diet treatment for Crohn's Disease?
Research suggests that reducing sulfur amino acids in the diet can have therapeutic benefits for gut-related conditions like ulcerative colitis, which shares some similarities with Crohn's Disease. This is because sulfur compounds can affect gut bacteria and inflammation, potentially impacting gut health.
12345Is a low sulfur diet safe for humans?
The studies suggest that dietary management, including elemental and exclusion diets, is generally safe for people with Crohn's disease, as it avoids the side effects of steroid treatments. However, it requires careful supervision to ensure proper nutrient intake and avoid potential deficiencies.
678910How does a low sulfur diet differ from other treatments for Crohn's disease?
A low sulfur diet for Crohn's disease is unique because it focuses on dietary changes rather than medication, potentially altering gut bacteria and reducing inflammation without the side effects of drugs. This approach is similar to elemental diets, which are known to improve nutritional status and reduce inflammation by excluding certain food components.
6791112Eligibility Criteria
This trial is for individuals with Crohn's disease who are not currently experiencing inflammation but still have symptoms like abdominal pain and diarrhea. They must have a prior diagnosis confirmed by tests, and low levels of fecal calprotectin or no inflammation seen in recent colonoscopy.Inclusion Criteria
I have been diagnosed with Crohn's disease through tests like endoscopy.
I have ongoing stomach pain or diarrhea with a score of 55 or more on the NIH PROMIS-GI scale.
My Crohn's disease is inactive, confirmed by tests.
Exclusion Criteria
I have had my entire colon removed.
I have an ileostomy or colostomy.
I haven't changed my immunosuppressive medications in the last 4 weeks.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (phone)
Treatment
Participants are randomized to receive a low sulfur diet or usual diet for 8 weeks. They will have in-person and phone visits, and undergo various tests.
8 weeks
2 visits (in-person), 4 visits (phone)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Optional Low Sulfur Diet Extension
Participants initially on the usual diet can opt for a low sulfur diet for an additional 8 weeks, with phone visits and testing.
8 weeks
1 visit (in-person), 3 visits (phone)
Participant Groups
The study compares the effects of an 8-week low sulfur diet to a usual diet on patients with Crohn's disease. Participants will receive dietary guidance from nutritionists and undergo various tests to assess gut health, including rectal sensation, bacterial overgrowth, and intestinal permeability.
2Treatment groups
Experimental Treatment
Active Control
Group I: Low Sulfur DietExperimental Treatment1 Intervention
Participants in this group will follow a low sulfur diet. This diet decreases the amount of animal products (including meat, dairy, and eggs) as well as sulfur additives in the diet. The main types of foods in the low sulfur diet include fruits, vegetables, whole grains, nuts, seeds, and soy products.
Group II: Usual DietActive Control1 Intervention
Participants in this group will follow a standard of care usual diet for 8 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MichiganAnn Arbor, MI
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Who Is Running the Clinical Trial?
University of MichiganLead Sponsor
References
Emerging aspects of gut sulfur amino acid metabolism. [2013]This review discusses the recent evidence indicating that sulfur amino acid metabolism in gastrointestinal tissues may be linked to human health and gut disease.
Colonic sulfide in pathogenesis and treatment of ulcerative colitis. [2019]A role for colonic sulfide in the pathogenesis and treatment of ulcerative colitis (UC) has emerged based on biochemical, microbiological, nutritional, toxicological, epidemiological, and therapeutic evidence. Metabolism of isolated colonic epithelial cells has indicated that the bacterial short-chain fatty acid n-butyrate maintains the epithelial barrier and that sulfides can inhibit oxidation of n-butyrate analogous to that observed in active UC. Sulfur for fermentation in the colon is essential for n-butyrate formation and sulfidogenesis aids disposal of colonic hydrogen produced by bacteria. The numbers of sulfate-reducing bacteria and sulfidogenesis is greater in UC than control cases. Sulfide is mainly detoxified by methylation in colonic epithelial cells and circulating red blood cells. The enzyme activity of sulfide methylation is higher in red blood cells of UC patients than control cases. Patients with UC ingest more protein and thereby sulfur amino acids than control subjects. Removing foods rich in sulfur amino acids (milk, eggs, cheese) has proven therapeutic benefits in UC. 5-Amino salicylic acid reduces fermentative production of hydrogen sulfide by colonic bacteria, and aminoglycosides, which inhibit sulfate-reducing bacteria, are of therapeutic benefit in active UC. Methyl-donating agents are a category of drugs of potential therapeutic use in UC. A correlation between sulfide production and mucosal immune responses in UC needs to be undertaken. Control of sulfidogenesis and sulfide detoxification may be important in the disease process of UC, although whether their roles is in an initiating or promoting capacity has yet to be determined.
The Sulfur Microbial Diet and Risk of Colorectal Cancer by Molecular Subtypes and Intratumoral Microbial Species in Adult Men. [2023]We recently described the sulfur microbial diet, a pattern of intake associated with increased gut sulfur-metabolizing bacteria and incidence of distal colorectal cancer (CRC). We assessed whether this risk differed by CRC molecular subtypes or presence of intratumoral microbes involved in CRC pathogenesis (Fusobacterium nucleatum and Bifidobacterium spp.).
Production and elimination of sulfur-containing gases in the rat colon. [2019]Highly toxic sulfur-containing gases have been pathogenetically implicated in ulcerative colitis. Utilizing a rat model, we studied the production and elimination of sulfur-containing gases within the unperturbed colon. The major sulfur-containing gases were hydrogen sulfide (H2S), methanethiol, and dimethyl sulfide with cecal accumulation rates of 2.6, 0.096, and 0.046 microliter/min, respectively. The dependence of H2S production on dietary components was demonstrated via a sixfold reduction with fasting and a fivefold increase with carrageenan (a nonabsorbable, sulfur compound) feeding. Zinc acetate reduced cecal H2S by fivefold, indicating the importance of H2S binding by divalent cations. During passage from the cecum to the rectum, > 90% of the sulfur gases were absorbed or metabolized. An H2 35S turnover of 97%/min was observed in the isolated cecum. Thus mucosal exposure is > 10 times the measured accumulation rate. Cecal mucosal tissue very rapidly metabolized H2S and methanethiol via a nonmethylating reaction.
Dietary sulfur amino acid supplementation reduces small bowel thiol/disulfide redox state and stimulates ileal mucosal growth after massive small bowel resection in rats. [2023]Following massive small bowel resection in animal models, the remnant intestine undergoes a dynamic growth response termed intestinal adaptation. Cell growth and proliferation are intimately linked to cellular and extracellular thiol/disulfide redox states, as determined by glutathione (GSH) and GSH disulfide (GSSG) (the major cellular redox system in tissues), and cysteine (Cys) and its disulfide cystine (CySS) (the major redox system in plasma), respectively. The study was designed to determine whether dietary supplementation with sulfur amino acids (SAA) leads to a greater reduction in thiol/disulfide redox state in plasma and small bowel and colonic mucosa and alters gut mucosal growth in an established rat model of short bowel syndrome (SBS). Adult rats underwent 80% jejunal-ileal resection (RX) or small bowel transection (surgical control) and were pair-fed either isonitrogenous, isocaloric SAA-adequate (control) or SAA-supplemented diets (218% increase vs. control diet). Plasma and gut mucosal samples were obtained after 7 d and analyzed for Cys, CySS, GSH, and GSSG concentrations by HPLC. Redox status (E(h)) of the Cys/CySS and GSH/GSSG couples were calculated using the Nernst equation. SAA supplementation led to a greater reduction in E(h) GSH/GSSG in jejunal and ileal mucosa of resected rats compared with controls. Resected SAA-supplemented rats showed increased ileal adaptation (increased full-thickness wet weight, DNA, and protein content compared with RX control-fed rats; increased mucosal crypt depth and villus height compared with all other study groups). These data suggest that SAA supplementation has a trophic effect on ileal adaptation after massive small bowel resection in rats. This finding may have translational relevance as a therapeutic strategy in human SBS.
Anti-inflammatory effects of enteral diet components on Crohn's disease-affected tissues in vitro. [2022]The mechanism of action of elemental diet in Crohn's disease treatment, is unknown. Alteration of bacterial flora, low antigenicity, low fat content and improvement of nutritional status are postulated to play a role in the anti-inflammatory effect of elemental diet.
Review article: the dietary management of Crohn's disease. [2019]Enteral feeding has been shown to be as effective as primary therapy for Crohn's disease, but it requires high patient motivation, may be unpalatable and is expensive. However, in adolescents with growth failure and when corticosteroid therapy is contra-indicated or has failed, it may become the treatment of choice. Furthermore, dietary therapy allows circumvention of the adverse side-effects of repeated courses of steroids. A number of different hypotheses have been proposed to explain the effect of enteral feeds but none has reached universal acceptance. Prospective trials suggest that the exclusion of whole protein is not necessary. Comparison of feeds with differing composition suggests that a low fat content increases efficacy and various explanations have been offered. The reduction of colonic bacterial load may also be important. Because symptoms of Crohn's disease may be provoked by eating, there is a risk of falsely attributing symptoms to specific foodstuffs. However, in many individuals foods can be identified which affect disease activity, and their exclusion leads to prolongation of disease remission. Dietetic supervision during food testing is important to avoid detrimental effects on nutrient and micronutrient intake.
Long-term effects of elemental and exclusion diets for Crohn's disease. [2019]Previous studies have confirmed the therapeutic value of elemental diets in promoting remission in active Crohn's disease, but their long-term benefit has not been established. Twenty-seven patients with established Crohn's disease who attained clinical remission after four weeks of enteral feeding were followed prospectively for up to 36 months. Twenty of these were willing to be tested for specific food intolerance using a pre-defined dietary elimination protocol; the others continued on a normal unrestricted diet. Eighteen patients (67%) have since relapsed; 89% of the relapse occurred within the first 6 months. Of the 15 patients with colonic involvement, 12 (80%) relapsed by 6 months. In contrast only 3 of 11 with isolated small bowel disease experienced early relapse. Of the 14 patients who completed the process of dietary testing, 5 could not identify any trigger foods; the remaining 9 were maintained on exclusion diets, 3 of whom relapsed early. Of the 11 taking a normal diet, 9 relapsed. Disease duration, previous intestinal resection or prior steroid therapy did not affect the relapse rate. Eight patients (31%) obtained a long-term remission, mean 23 months (range 12-36 months), without any medication. Long-lasting remissions can be obtained in about one-third of patients with Crohn's disease following treatment with a defined formula diet. Colonic involvement is associated with a high early relapse rate.
Dietary fat attenuates the benefits of an elemental diet in active Crohn's disease: a randomized, controlled trial. [2019]Although an elemental diet has been established as the primary treatment for patients with Crohn's disease, the influence of dietary fat on the elemental diet remains unclear. We have designed the first randomized, controlled trial for elemental diets containing different fat percentages in patients with active Crohn's disease.
Pilot study of an elimination diet in adults with mild to moderate Crohn's disease. [2023]There remains limited data supporting the efficacy of dietary therapy in adults with Crohn's disease (CD). This was a pilot study of the McMaster Elimination diet for CD (MED-CD), which excludes several potentially detrimental ingredients commonly found in the Western diet.
Remission following an elemental diet or prednisolone in Crohn's disease. [2022]The short- and long-term effects of an elemental diet in children with acute Crohn's disease were compared with those of prednisolone in historical controls. Clinical remission was induced in 25 of 30 and in 18 of 28 episodes treated for six weeks with an elemental diet and prednisolone. Patients with proximal disease had longer remission after treatment with an elemental diet (p
[Status of elemental diets in the therapy of Crohn disease in childhood]. [2009]Since the seventieth low molecular weight formulas, "elemental diets", are applied in acute Crohn's disease in addition to drug therapy. In small bowel involvement, therapeutic efficiency in active disease is as good as salazosulfapyridine combined with corticosteroids. Physiological changes under elemental diet have been reported: decrease of gastric and pancreatic secretion, changes of bacterial bowel flora and in patients with Crohn's disease decreased fecal bile acid excretion and decreased intestinal losses of lymphocytes were described. Further, the absence of allergens in the formula and the quick and complete resorption are discussed to be important to clinical improvement in Crohn's disease. Indications for elemental diet are acute small bowel disease, intestinal obstruction, malnourishment and growth retardation. Further studies are needed to examine if elemental diets are effective in gastrointestinal fistulas and extraintestinal symptoms in Crohn's disease.