. 2024 Dec 4;24:1493. doi: 10.1186/s12885-024-13234-1

Table 1.

DIET eligibility criteria

Inclusion Criteria	Exclusion Criteria
• Age ≥ 18 years old. • Body Mass Index 18.5–40 kg/m2 • ECOG performance status of 0 or 1 • English-speaking • Self-reported willingness to exclusively eat the provided diets • Self-reported willingness to comply with scheduled visits, undergo venipuncture, and provide stool samples	• Ongoing colitis or diarrhea • History of ≥ Grade II colitis or diarrhea on ICB • Unresolved ≥ Grade III immune-related adverse event on ICB (other than endocrinopathy requiring hormone replacement) • History of active inflammatory bowel disease • Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment • History of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted). • Medical contraindications to intervention as determined by the treating physician • Self-reported major dietary restrictions related to intervention • Diagnosis of diabetes mellitus type I or type II that requires medical treatment or random glucose > 200 mg/dL • Antibiotic use within 21 days of planned start of equilibration diet • Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. • Regularly taking probiotics, fiber supplements, or any other medication or supplement that could affect study outcome as determined by the principal investigator and unable/unwilling to discontinue for the purpose of the study. These agents must be discontinued at least 14 days prior to start of diet. • Currently consuming an average estimated daily fiber intake exceeding 20 g based on the results of the preliminary dietary assessment; vegetarian or vegan • Current smoker or heavy drinker (defined as > 14 drinks per week) or current self-reported illicit drug use • Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements. • Plan for travel during the study that would preclude adherence to prescribed diets

Inclusion Criteria

Exclusion Criteria

• Age ≥ 18 years old.

• Body Mass Index 18.5–40 kg/m2

• ECOG performance status of 0 or 1

• English-speaking

• Self-reported willingness to exclusively eat the provided diets

• Self-reported willingness to comply with scheduled visits, undergo venipuncture, and provide stool samples

• Ongoing colitis or diarrhea

• History of ≥ Grade II colitis or diarrhea on ICB

• Unresolved ≥ Grade III immune-related adverse event on ICB (other than endocrinopathy requiring hormone replacement)

• History of active inflammatory bowel disease

• Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment

• History of total colectomy or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e., restrictive procedures such as banding, are permitted).

• Medical contraindications to intervention as determined by the treating physician

• Self-reported major dietary restrictions related to intervention

• Diagnosis of diabetes mellitus type I or type II that requires medical treatment or random glucose > 200 mg/dL

• Antibiotic use within 21 days of planned start of equilibration diet

• Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study intervention administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

• Regularly taking probiotics, fiber supplements, or any other medication or supplement that could affect study outcome as determined by the principal investigator and unable/unwilling to discontinue for the purpose of the study. These agents must be discontinued at least 14 days prior to start of diet.

• Currently consuming an average estimated daily fiber intake exceeding 20 g based on the results of the preliminary dietary assessment; vegetarian or vegan

• Current smoker or heavy drinker (defined as > 14 drinks per week) or current self-reported illicit drug use

• Uncontrolled concurrent illness or infection or psychiatric illness/social situations that would limit compliance with study requirements.

• Plan for travel during the study that would preclude adherence to prescribed diets