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To evaluate the effect and tolerance of a plant based diet in reducing the flare of clinical symptoms in patients with ulcerative colitis who are asymptomatic at time of study

A Randomized Controlled Trial to Evaluate Efficacy and Tolerability of Plant Based Diet in Maintaining Remission in Patients with Ulcerative Colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041032
Enrollment
96
Registered
2022-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K519- Ulcerative colitis, unspecified

Interventions

Intervention1: plant based diet: Patients in the intervention arm will be advised a plant based diet, which would be rich in dietary constituents that will promote healthy microbiota and improve the i

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age between 18 â?? 80 years 2. Patients with clinical remission for 3month as assessed by simple clinical colitis activity index (SCCAI 0-2) 3. Patients on stable doses of 5-ASA (5-amino salicylic acid) for past 4 weeks 4. Patients on stable doses of azathioprine/6-mercaptopurine for past 3 months 5. Last steroid intake- 6 months prior 6. Patients giving consent for plant based diet 7. Patients who agree to adhere to the diet schedule

Exclusion criteria

Exclusion criteria: 1. Patients with disease activity (SCCAI >=3) 2. Patients on steroids 3. Patients who have received topical 5-ASA or topical steroids in the past 2 weeks 4. Patients with H/O of antibiotic exposure in the past 4 weeks 5. Patients requiring hospitalization 6. Patients with H/O bowel surgery 7. Patients with concomitant GI infection 8. Pregnancy 9. Patients with other co morbid illnesses 10. Patients not giving consent for plant based diet 11. Patients who disagree to adhere to the diet schedule

Design outcomes

Primary

MeasureTime frame
1. Clinical relapse as defined by increase in SCCAI â?¥3 for more than 7 days 2. Change in microbiome composition as evaluated by 16srRNA analysisTimepoint: 1. Clinical relapse as defined by increase in SCCAI â?¥3 for more than 7 days 2. Change in microbiome composition as evaluated by 16srRNA analysis—

Secondary

MeasureTime frame
1. Adherence to plant based diet. 2. Quality of life at 1 year as assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) (Appendix A). 3. Patient related outcome measures (PROMs)Timepoint: 1 year—

Countries

India

Contacts

Public ContactProfessor Vineet Ahuja

All India Institute of Medical Sciences

Vineet.aiims@gmail.com9868397206

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026