Colonic bacterial dysbiosis as a cause of infant proctocolitis

Colonic bacterial dysbiosis as a cause of infant proctocolitis - BaktDysFPIP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00006209

Enrollment

100

Registered

2014-06-12

Start date

2015-05-06

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

FOOD PROTEIN INDUCED INFANTPROCTOCOLITIS

Interventions

Group 1: Group 1: Food protein induced proctocolitis patients Stool samples weeks 0, 4, and 8. Analysis: bakterial stool culture, K. oxytoca toxin analysis, K. oxytoca MLST analysis, microbiota analy

Eligibility

Sex/Gender

All

Age

2 Weeks to 24 Weeks

Inclusion criteria

Inclusion criteria: Streaky bloody (mucous) stools, otherwise well-appearing child Blood confirmed by hem-occult test GI-infectious work-up negative Abdominal ultrasound (unremarkable), blood count, CRP, skin-prick test already performed

Exclusion criteria

Exclusion criteria: Previous anaphylactic (Type 1) reaction to food proteins (immediate skin reaction, respiratory symptoms, shock) Current antibiotic treatment

Design outcomes

Primary

Measure	Time frame
enteral microbiota descriptive analysis Stool samples weeks 0, 4, and 8. microbiota analysis (16s-rRNA, metagenomics)	—

Secondary

Measure	Time frame
Klebsiella oxytoca frequency and toxin analysis Stool samples weeks 0, 4, and 8. Analysis: bakterial stool culture, K. oxytoca toxin analysis, K. oxytoca MLST analysis	—

Countries

Austria

Contacts

Public ContactKarl Martin Hoffmann

Klinische Abteilung für Allgemeine PädiatrieUniv. Klinik für Kinder- und JugendheilkundeMedizinische Universität Graz

hoffmaka@mac.com+43 316 385 83729

Outcome results

None listed

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