Low Sulfur Diet for Crohn's Disease

Overseen By Merrick Bay

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Antibiotics, Probiotics

Disqualifiers: Total colectomy, Ileostomy, Vegan, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a low sulfur diet can benefit people with Crohn's disease. Participants will either follow a low sulfur diet, which reduces animal products and sulfur additives, or maintain their usual diet for 8 weeks. The study includes nutritionist support, dietary education, and several in-person and phone visits. It suits individuals with Crohn's disease who experience ongoing symptoms like abdominal pain and diarrhea but have no current inflammation. Participants should not follow a vegetarian or vegan diet and must be able to adhere to a low sulfur diet. As an unphased study, this trial offers a unique opportunity to contribute to understanding dietary impacts on Crohn's disease.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that most people can easily follow a low sulfur diet. Studies have found that reducing sulfur intake can alter gut bacteria, potentially alleviating Crohn's disease symptoms.

In previous studies, participants on a low sulfur diet did not experience serious side effects. However, mild digestive changes may occur as the body adjusts to the new diet.

For those considering joining the study, this diet involves consuming more fruits, vegetables, whole grains, nuts, seeds, and soy products, while reducing intake of meat, dairy, eggs, and foods with sulfur additives. Overall, current evidence suggests the diet is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Low Sulfur Diet is unique because it takes a dietary approach to managing Crohn's disease, focusing on reducing sulfur intake from animal products and additives. Unlike standard treatments, which often involve medications like anti-inflammatories and immune suppressants, this diet emphasizes consuming fruits, vegetables, whole grains, nuts, seeds, and soy products. Researchers are excited about this approach because it could offer a natural, non-pharmaceutical way to help manage the symptoms of Crohn's disease, potentially reducing side effects associated with long-term medication use.

What evidence suggests that a low sulfur diet might be an effective treatment for Crohn's disease?

This trial will compare a Low Sulfur Diet with a Usual Diet for participants with Crohn's disease. Research has shown that reducing sulfur intake might benefit people with Crohn's disease. Studies have found that cutting down on sulfur can positively alter the gut's microbial composition. One study discovered that diets high in sulfur are linked to worse symptoms in conditions like ulcerative colitis. New evidence suggests that consuming fewer animal products and sulfur additives could reduce gut inflammation. This offers hope that a low sulfur diet might improve Crohn's disease symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Allen Lee, MD, MS

Principal Investigator

Assistant Professor

Are You a Good Fit for This Trial?

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 haven't changed my immunosuppressive medications in the last 4 weeks.

I have had my entire colon removed.

I have an ileostomy or colostomy.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Low Sulfur Diet
• Usual Diet

Trial Overview

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.

How Is the Trial Designed?

Group I: Low Sulfur Diet Experimental Treatment 1 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 Diet Active Control 1 Intervention

Participants in this group will follow a standard of care usual diet for 8 weeks.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

In a pilot study involving 17 adults with mild to moderate Crohn's disease, a 2-week treatment with oral enteral nutrition followed by a 12-week McMaster Elimination diet led to satisfactory adherence in most participants, with 38.5% achieving clinical remission by week 14.

The study showed that 46.2% of participants experienced an endoscopic response, indicating that the dietary intervention may effectively reduce disease activity in Crohn's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of an elimination diet in adults with mild to moderate Crohn's disease. Narula, N., Wong, ECL., Moayyedi, P., et al.[2023]

Elemental diet significantly increases the anti-inflammatory cytokine interleukin-1 receptor antagonist compared to interleukin-1beta in colonic biopsies from Crohn's disease patients, suggesting a potential mechanism for its therapeutic effects.

Both elemental diet and casein show similar anti-inflammatory effects in Crohn's disease tissue, indicating that the benefits are not solely due to the amino acid composition of the elemental diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-inflammatory effects of enteral diet components on Crohn's disease-affected tissues in vitro. Meister, D., Bode, J., Shand, A., et al.[2022]

An elemental diet was more effective than prednisolone in inducing clinical remission in children with acute Crohn's disease, particularly for those with proximal disease, showing longer remission periods.

Children on an elemental diet experienced significantly better improvements in growth, nutritional status, and overall health markers compared to those treated with steroids, highlighting its potential as a superior treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remission following an elemental diet or prednisolone in Crohn's disease. Papadopoulou, A., Rawashdeh, MO., Brown, GA., et al.[2022]

Elemental diets, used alongside drug therapy, show therapeutic effectiveness in treating active Crohn's disease, particularly in cases of small bowel involvement, comparable to traditional treatments like salazosulfapyridine and corticosteroids.

The elemental diet leads to physiological changes that may contribute to its effectiveness, such as reduced gastric and pancreatic secretions, altered gut bacteria, and improved nutrient absorption, making it suitable for conditions like acute small bowel disease and malnourishment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Status of elemental diets in the therapy of Crohn disease in childhood]. Kirchmann, HM.[2009]

Enteral feeding can be an effective primary therapy for Crohn's disease, especially in adolescents with growth failure when corticosteroids are not suitable, as it helps avoid the side effects of steroids.

While the exact mechanisms of how enteral feeding works are not fully understood, studies suggest that low-fat diets may enhance efficacy and that identifying and excluding certain foods can help prolong remission in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: the dietary management of Crohn's disease. King, TS., Woolner, JT., Hunter, JO.[2019]

The gastrointestinal tract metabolizes a significant portion of dietary methionine, with 20% being processed, which plays a crucial role in producing homocysteine and cysteine, both of which are linked to gut health and disease.

Elevated levels of homocysteine in the intestinal mucosa may contribute to inflammation and endothelial dysfunction in conditions like inflammatory bowel disease, suggesting that dietary interventions with folate and cysteine could be beneficial for prevention and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging aspects of gut sulfur amino acid metabolism. Burrin, DG., Stoll, B.[2013]

In a randomized controlled trial involving 28 patients with active Crohn's disease, a low-fat elemental diet (3.06 g/day) resulted in an 80% remission rate after 4 weeks, significantly outperforming medium (40%) and high-fat (25%) diets.

The study suggests that high levels of long-chain triglycerides in elemental diets may reduce their effectiveness in treating active Crohn's disease, indicating that dietary fat content is crucial for therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary fat attenuates the benefits of an elemental diet in active Crohn's disease: a randomized, controlled trial. Bamba, T., Shimoyama, T., Sasaki, M., et al.[2019]

In a study of 27 patients with Crohn's disease who achieved remission after 4 weeks of enteral feeding, 67% experienced a relapse within 36 months, with 89% of these relapses occurring within the first 6 months, particularly among those with colonic involvement (80% relapse rate).

Despite the high relapse rates, about 31% of patients maintained long-term remission (average of 23 months) without medication after following a defined formula diet, indicating that specific dietary interventions can lead to sustained remission in some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of elemental and exclusion diets for Crohn's disease. Giaffer, MH., Cann, P., Holdsworth, CD.[2019]

In a rat model, the study found that hydrogen sulfide (H2S) is produced in significant amounts in the colon, with production rates influenced by diet, showing a sixfold reduction during fasting and a fivefold increase with sulfur-rich carrageenan feeding.

The research demonstrated that over 90% of sulfur-containing gases are absorbed or metabolized as they move through the colon, indicating that the mucosal tissue rapidly processes these gases, which may have implications for understanding their role in conditions like ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Production and elimination of sulfur-containing gases in the rat colon. Suarez, F., Furne, J., Springfield, J., et al.[2019]

Dietary supplementation with sulfur amino acids (SAA) significantly improved the redox state in the gut mucosa of rats after massive small bowel resection, indicating a potential mechanism for enhancing gut health.

SAA supplementation led to notable increases in ileal adaptation, including greater tissue weight, DNA, and protein content, suggesting it could be a beneficial treatment strategy for humans with short bowel syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary sulfur amino acid supplementation reduces small bowel thiol/disulfide redox state and stimulates ileal mucosal growth after massive small bowel resection in rats. Shyntum, Y., Iyer, SS., Tian, J., et al.[2023]

Sulfide production in the colon is linked to ulcerative colitis (UC), with higher levels of sulfate-reducing bacteria found in UC patients compared to controls, suggesting a potential role in the disease's pathogenesis.

Dietary changes, such as reducing sulfur amino acids from foods like milk and eggs, have shown therapeutic benefits for UC, indicating that managing sulfide levels could be an effective treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonic sulfide in pathogenesis and treatment of ulcerative colitis. Roediger, WE., Moore, J., Babidge, W.[2019]

In a study of 48,246 men over 26 years, a sulfur microbial diet was linked to an increased risk of distal colorectal cancer (CRC), particularly in cases with high levels of prostaglandin synthase 2 (PTGS2), suggesting a potential molecular subtype vulnerability.

The risk associated with the sulfur microbial diet was notably higher for distal CRC in individuals lacking intratumoral Bifidobacterium spp., indicating that gut microbial composition may influence cancer risk related to dietary patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Sulfur Microbial Diet and Risk of Colorectal Cancer by Molecular Subtypes and Intratumoral Microbial Species in Adult Men. Sikavi, DR., Nguyen, LH., Haruki, K., et al.[2023]

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