Effect of Genistein (a soyabean extract) in patients suffering from Ulcerative Colitis

Effect of Genistein on Fecal Microbial Diversity, Modified Mayo Score, and Biomarkers in Patients with Ulcerative Colitis: A Placebo-Controlled Study. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083415

Enrollment

Registered

2025-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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: Genistein: 500 mg BD, orally, 6 months Control Intervention1: Placebo: 500 mg BD, orally, 6 months

Eligibility

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis of mild-to-moderate UC based on clinical, endoscopic, and histological criteria. 2. Modified Mayo Score between 3 and 6 at baseline 3. Adult patients aged 18 75 years 4. Patients capable of providing informed consent 5. Ongoing stable-dose UC medications must be continued. 6. Participants must not have received probiotics, antibiotics, or corticosteroids more than 20 mg/day in the past 8 weeks. 7. Willingness to maintain a stable diet for 6 months. 8. Willing to avoid probiotics, antibiotics (unless medically necessary), and corticosteroid use more than 20 mg/day. 9. No topical 5-ASA therapy

Exclusion criteria

Exclusion criteria: 1. Severe or fulminant UC (Mayo Score more than 6). 2. Patients requiring urgent surgical intervention or colectomy 3. Recent use of biologics or small molecules (less than or equal to 6 months before enrolment). 4. Use of systemic corticosteroids more than 20 mg/day. 5. Other gastrointestinal diseases (Crohn s disease, microscopic colitis, infectious colitis). 6. Active infections requiring systemic antibiotics. 7. Pregnant or breastfeeding women (due to potential unknown effects of Genistein). 8. Liver or kidney dysfunction (LFT or RFT abnormalities).

Design outcomes

Primary

Measure	Time frame
Changes in fecal microbial diversity, Shannon index and Beta diversity.Timepoint: 6 months	—

Secondary

Measure	Time frame
1. Reduction in Modified Mayo Score. Timepoint: 6 months;2. Improvement in fecal calprotectin and CRP.Timepoint: 6 months;3. Endoscopic healing (mucosal appearance at colonoscopy). Timepoint: 6 months;4. Assessment of safety and adverse eventsTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Rajiv Mehta

SIDS hospital and research centre

rmgastro@yahoo.com9879863510

Outcome results

None listed

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