Ulcerative colitis Digestive System
Conditions
Interventions
The study is single center, open label, quasi experimental trial of partial enteral nutrition (PEN) and exclusion diet in comparison to standard medical therapy in adult patients with mild to moderate
Sponsors
All India Institute of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who are confirmed cases of mild to moderate ulcerative colitis 2. Age: 18 – 70 years of either gender 3. Patients on stable dose of mesalamine for past 4 weeks 4. Patients on stable dose of azathioprine/6-mercaptopurine for past 6 months 5. Patients on stable doses of topical therapy for past 2 weeks 6. Patients who are willing to participate
Exclusion criteria
Exclusion criteria: 1. Received oral steroids in the past 4 weeks 2. Received oral antibiotics within past 2 weeks 3. Patients with severe disease activity 4. Patients with fulminant colitis requiring hospitalization 5. Patients who have had surgery 6. Patients with concomitant GI infection 7. Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases will also be excluded 8. Pregnant, lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of clinical remission (assessed by simple clinical colitis activity index (SCCAI)=2) and faecal calprotectin <150ug/gm at 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in microbiome at 4 weeks after partial enteral nutrition (PEN) and exclusion diet in the intervention arm 2. Proportion of patients with rectal bleeding score of 0 and stool frequency score of =1 at 4 weeks 3. Tolerability of PEN + exclusion diet at 4 weeks | — |
Countries
India
Contacts
Public ContactVineet Ahuja
Outcome results
None listed