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Clinical effect of protein oligopeptide on ulcerative colitis

Clinical effect of protein oligopeptide on ulcerative colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102563
Enrollment
Unknown
Registered
2025-05-16
Start date
2024-07-19
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Ulcerative colitis

Interventions

Placebo group(Phase of activity):Maltodextrin 5g/d
Intervention group-Albumin oligomeric peptide group(Phase of activity):Albumin oligomeric peptide 5g/d
Intervention group-Fish skin collagen oligopeptide group(Phase of activity):Fish skin collagen oligopeptide 5g/d
Blank control group(Phase of activity):None
Intervention group-Albumin oligomeric peptide group(Phase of remission):Albumin oligomeric peptide 5g/d
Intervention group-Fish skin collagen oligopeptide group(Phase of remission):Fish skin collagen oligopeptide 5g/d
Blank control group(Phase of remission):None

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with ulcerative colitis diagnosed through clinical, endoscopic, radiological, and histological criteria; 2. Aged between 18-80 years; 3. Patients in remission are defined as having a modified Mayo score of =3; 4. Prior to enrollment, stable doses of maintenance therapy for ulcerative colitis are required: oral stable aminosalicylates, at least 3g mesalamine or equivalent medications, not exceeding 4.8g; before baseline, corticosteroids must be taken at <=20mg or equivalent medications (which can be gradually reduced according to clinical needs), with azathioprine taken for 6 weeks or biologics for 8 weeks; 5. Non-steroidal anti-inflammatory drugs, probiotics, prebiotics, enteral nutrition products, etc., cannot be used for 1 month prior to enrollment; 6. Voluntarily sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Concurrent severe liver, heart, lung, or kidney diseases; 2. Abdominal abscess, toxic megacolon, partial or total colonic resection, unresected adenomatous colonic polyps, or colonic mucosal dysplasia; 3. Obese patients (BMI > 27.9 kg/m^2), patients with metabolic syndrome, malignancies, and/or metabolic diseases (such as hyperthyroidism, diabetes); 4. Pregnant or breastfeeding individuals; 5. Taking more than 20 mg of oral prednisone or equivalent medications, using methotrexate, or subjects not receiving treatment; 6. Known allergy to fish skin collagen oligopeptides and albumin oligopeptides.

Design outcomes

Primary

MeasureTime frame
Modified Mayo score;Clinical recurrence occurred within 6 months;

Secondary

MeasureTime frame
Inflammatory Bowel Disease Questionnaire, IBDQ;Ulcerative Colitis Endoscopic Index of Severity (UCEIS);Blood biochemical index;Fecal Microbiota;Colonic mucosal barrier function;Metabolome;Body Composition Analysis;Blood inflammatory factors;Fecal calprotectin;

Countries

China

Contacts

Public ContactWang Dandan

Affiliated Hospital of Qingdao University

1067963509@qq.com+86 186 6180 5625

Outcome results

None listed

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