K51
Conditions
Interventions
Group 1: L-glutamine, 10g/day p.o. (powder, in the form of two 5 g doses to be dissolved in 125 ml water at room temperature with the morning and evening meal), for 14 days.
Group 2: Protifar, 10g/day
Sponsors
Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences, Grant no. 502-14-15200100-45007 from the PUMS statutory subsidy for young scientists
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Inclusion criteria
Inclusion criteria: Control group - Age 8-18. Informed consent of the study participant/legal guardian. Study group - Age 8-18. Minimum 30 kg body weight. Diagnosis of UC. Introduction of biological treatment of UC (0.2 regimen). Informed consent of the study participant/legal guardian.
Exclusion criteria
Exclusion criteria: Control group - Significant disease burden (serious general condition, chronic disease). Antibiotic cycle in the last six months. Pregnancy. Withdrawal of informed consent. Study group - Serious general condition. Surgical intervention within the gastrointestinal tract. Pregnancy. Non-compliance. Withdrawal of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in serum laboratory markers in children with ulcerative colitis (blood sampling before and after a 14-day intervention, serum, enzyme-linked immunosorbent assay (ELISA)). | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the effect of glutamine intake on laboratory markers of intestinal homoeostasis (blood sampling before and after a 14-day intervention, serum, ELISA): A) Change from baseline in serum lactoferrin concentration in children with ulcerative colitis, depending on the implemented supplementation with l-glutamine or placebo. B) Change from baseline in serum zonulin concentration in children with ulcerative colitis, depending on the implemented supplementation with l-glutamine or placebo. Examination of the effect of glutamine intake on the level of RUNX3 methylation (DNA isolation from frozen whole blood, DNA, methylation-sensitive high-resolution melting (MS-HRM)): A) Change in RUNX3 methylation level in children with ulcerative colitis vs healthy individuals. B) Change in RUNX3 methylation level after glutamine supplementation in children with ulcerative colitis. Assessment of the patient’s clinical condition (medical history, Paediatric Ulcerative Colitis Activity Index (PUCAI)): A) Change in the clinical characteristics and ulcerative colitis treatment effects in relation to serum laboratory markers, RUNX3 methylation level and glutamine supplementation in children. | — |
Countries
Poland
Contacts
Public ContactJaroslaw Walkowiak
Department of Pediatric Gastroenterology and Metabolic Diseases, Poznan University of Medical Sciences
Outcome results
None listed