Evaluating the relationship between nitric oxide content in type 3 natural lymphocytes and severity of enteritis and response to drug intervention in patients with inflammatory bowel disease: an investigator initiated, open-label, clinical trial

A clinical trial to evaluate the relationship between nitric oxide content in type 3 natural lymphocytes and severity of enteritis and response to drug intervention in patients with inflammatory bowel disease

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083224

Enrollment

Unknown

Registered

2024-04-18

Start date

2024-04-19

Completion date

Unknown

Last updated

2024-09-09

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

Conditions

Inflammatory Bowel Disease

Interventions

Trial group:Berberine hydrochloride tablets mesalazine for 8w

Control group:mesalazine

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65. (2) The patient gave informed consent to the study and filled in the CRF form, blood test and colonoscopy as required. (3) Meet the diagnostic criteria of IBD.

Exclusion criteria

Exclusion criteria: (1) The patient had received treatment related to hormones, immunosuppressants (azathioprine, cyclosporine, methotrexate), and biological agents (infliximab, Adalimumab, Vederizumab, and ulinumab) within 3 months. (2) Complicated with serious heart, liver, lung, kidney, blood, endocrine, nervous system diseases and autoimmune diseases. (3) Respiratory tract, digestive tract, urinary tract and other infections. (4) History of abdominal surgery other than appendicitis. (5) Antibiotics and systemic hormones have been used in the past 1 month. (6) Take intestinal microecological preparations, laxatives and antidiarrheal drugs continuously for more than 3 days within the past 2 weeks. (7) Pregnant and lactating women. (8) Patients with serious mental disorders, such as schizophrenia, bipolar disorder, etc.

Design outcomes

Primary

Measure	Time frame
NO in IL3 cells ;Modified Mayo score;CDAI score ;CDEIS score ;	—

Secondary

Measure	Time frame
Bristol stool scale;IBDQ;Changes of fecal flora;Fecal calcarein;Blood inflammation index;	—

Countries

China

Contacts

Public ContactLi Jun

Peking University Third Hospital

yanwt2003@163.com+86 183 1147 1557

Outcome results

None listed

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