Status:
UNKNOWN
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations wit...
Detailed Description
This randomized, parallel-group feeding study will examine the influence of Mediterranean and SCD diets on gut microbiota, luminal inflammation, and disease-specific clinical indices in patients with ...
Eligibility Criteria
Inclusion
- History of active ulcerative colitis for at least 3 months before screening
- Ulcerative colitis confirmed by colonoscopy or flexible sigmoidoscopy within 2 years of screening
- Mild to moderate ulcerative colitis at the time of screening (2 \< Mayo score \< 12)
- 1 ≤ Endoscopy subscore ≤ 2, or fecal calprotectin \> 150 mcg/g within 2 weeks of screening
- Patients on 5-aminosalicylates (e.g. mesalamine, etc.) must be on a stable dose for ≥ 4 weeks prior to screening
- Patients on treatment with immunosuppressive (azathioprine/6-mercaptopurine and methotrexate) or biologic medications (infliximab, adalimumab, and golimumab) must be on stable dose for 8 weeks prior to baseline
- At the time of baseline, patients may be on no more than 20 mg of prednisone and 9 mg of budesonide MMX
Exclusion
- Patients with Crohn's disease or indeterminate colitis
- History of colectomy
- Presence of ileal pouch or ostomy
- History of colonic dysplasia
- Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova \& parasites, clostridium difficile, and stool culture
- Severe to fulminant colitis
- Recent hospitalizations (within 2 weeks of screening) for ulcerative colitis requiring IV steroids
- Recent systemic antibiotics use (within 2 weeks of screening)
- Presence of the following labs indicative of severe colitis: a. Hemoglobin \< 8.0 g/dl b. Albumin \< 3.0 g/dl
- Use of Total Parenteral Nutrition (TPN)
- Active use of anti-diarrheal medications
- Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04398550
Start Date
September 3 2020
End Date
December 31 2023
Last Update
May 31 2022
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114