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Assessment of GLUtamine-induced changes in the gut microbiota of children with Ulcerative Colitis using nanopore sequencing: a randomized trial

Assessment of GLUtamine-induced changes in the gut microbiota of children with Ulcerative Colitis using nanopore sequencing: a randomized trial - GLUBIOT-UC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030782
Enrollment
60
Registered
2023-02-22
Start date
2023-02-27
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

K51

Interventions

Group 1: (Patients with ulcerative colitis - randomized) Glutamine (powder), 0.2 g/kg of body mass, daily, orally, in two doses Group 2: (Patients with ulcerative colitis - randomized) High protein su

Sponsors

Department of Pediatric Gastroenterology and Metabolic DiseasesPoznan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with UC (n=40, randomized): PUCAI not larger than 20, age 8-18 years. ; Inclusion criteria for a supplemental control group undergoing one assessment of microbiota (n=20): age 8-18 years, no current use of medications, no important signs or symptoms of disease, no antibiotic therapy in the past half a year, no history of surgical interventions that would importantly modify the anatomy of the gastrointestinal tract.

Exclusion criteria

Exclusion criteria: Exclusion from the study - patients (n=40): severe disease course, pregnancy, colectomy, consent withdrawal; Exclusion from the study - controls (n=20): important disease or disease necessitating antibiotic therapy, pregnancy, withdrawal of consent, taking probiotics

Design outcomes

Primary

MeasureTime frame
Quantitative and qualitative properties of the fecal microbiota

Secondary

MeasureTime frame
Fecal calprotectin concentration, methylation of ALPI gene (Alkaline phosphatase, intestinal), symptoms (Pediatric Ulcerative Colitis Activity Index and its items)

Countries

Poland

Contacts

Public ContactJan Nowak

Department of Pediatric Gastroenterology and Metabolic DiseasesPoznan University of Medical Sciences

pedgastro@ump.edu.pl+48618491432

Outcome results

None listed

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