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Mechanism study of 4.1R regulating inflammatory bowel disease in children through macrophages

Mechanism study of 4.1R regulating inflammatory bowel disease in children through macrophages

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098507
Enrollment
Unknown
Registered
2025-03-10
Start date
2023-12-01
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Crohn's disease, ulcerative colitis

Interventions

PUC group:None
Control group:None

Sponsors

Henan Children's Hospital Zhengzhou Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Inclusion criteria for PUC: (1) Clinical manifestations: intermittent or persistent abdominal pain, diarrhea, bloody stools for at least 4 weeks, with or without systemic symptoms such as weight loss, fever, anemia, etc; (2) Under electronic colonoscopy, there are continuous erosions, shallow ulcers, etc. in the colon, and the mucosa may appear granular, brittle, and prone to bleeding, with disappearance of vascular texture; (3) Gastrointestinal barium meal imaging: Multiple small filling defects are observed in the intestinal wall, and the colon intestine appears as a lead tube; (4) Pathological histology examination: inflammatory cell infiltration and changes in crypt structure; 1) .Structural changes in crypts include branching, twisting, atrophy and irregularities on the mucosal surface; 2) .Inflammatory cell infiltration, that is, focal or diffuse basal plasma cell increase, acute and chronic inflammatory cell infiltration in the lamina propria propria, forming cryptitis, crypt abscess, etc. Meeting (1)+{(2) or (3)}+(4) confirms the diagnosis of UC. 2.PCD inclusion criteria: (1) Children with recurrent abdominal pain, diarrhea, fever, or coexisting extraintestinal manifestations such as nodular erythema, gangrenous pyoderma, scleritis, uveitis, and recurrent oral ulcers; (2) Colonoscopy shows a) discontinuous lesions b) pebble like mucosa or longitudinal ulcers c) changes in whole wall inflammatory response d) non caseous granulomas e) fissures and fistulas f) anal lesions; (3) Exclude diseases such as intestinal tuberculosis, Behcet's disease, lymphoma, appendicitis, and UC. Diagnosis basis: After excluding the above diseases, a, b, and c are suspected diagnoses; Adding one of d, e, and f can confirm the diagnosis; Individuals with d, along with any two of a, b, and c, can also be diagnosed. 3.Inclusion criteria for the control group: Referring to the Rome IV diagnostic criteria for functional abdominal pain (FAP) in children: (1) episodic or persistent abdominal pain; (2) Not meeting the criteria for other functional gastrointestinal diseases (FGID); (3) No evidence of inflammatory, anatomical, metabolic abnormalities or tumors that can explain the symptoms; (4) Pain can occur at least once a week and last for at least 2 months; (5) Age range from 2 to 14 years old.

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria for PUC and PCD: (1) those with infectious diseases or autoimmune disease; (2) Individuals with a history of using antibiotics, glucocorticoids, and immunosuppressants within the past month. 2.Exclusion criteria for the control group: (1) Abdominal pain caused by infection or clinically relevant organic lesions, as evidenced by relevant auxiliary examinations or symptoms, physical examination, and extraintestinal diseases; (2) Merge with other acute and chronic diseases; (3) Due to incomplete observation data, it affects the efficacy and safety assessment.

Design outcomes

Primary

MeasureTime frame
CD4+T cells, CD8+T cells, M1 macrophages, M2 macrophages, 4.1R protein;Macrophage associated inflammatory factors such as GM-CSF, M-CSF, IL-1 ß, IL-4, IL-6, IL-10, IL-13, IFN - ?, iNOS, TNF - a, Arg1, Arg2, CCL2, TGF - ß, CD40, etc;

Secondary

MeasureTime frame
General information (gender, age, etc.), clinical symptoms (fever, abdominal pain, diarrhea, rectal bleeding, perianal lesions, other extraintestinal manifestations);ESR, CRP, blood routine, liver and kidney function;

Countries

China

Contacts

Public ContactLi Xiaoqin

Henan Children's Hospital Zhengzhou Children’s Hospital

15890105818@163.com+86 371 85515835

Outcome results

None listed

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