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The effect of IV iron on the gut microbiome in patients with metastatic colorectal cancer

An exploratory study on the effect of intravenous iron supplementation on gut microbiome in patients with metastatic colorectal cancer accompanied by iron deficiency anemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007895
Enrollment
60
Registered
2022-11-11
Start date
2022-11-01
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Interventions

None listed

Sponsors

Korea University Anam Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Signed written informed consent obtained prior to the study ? Men and women ? 19 years of age ? Eastern Cooperative Oncology Group(ECOG) Performance Status 0 ~ 2 ? Histologically confirmed colorectal adenocarcinoma ? Treatment naive patients scheduled to undergo 1L FOLFOX-based palliative chemotherapy ? Hb 8.0-11.0g/dL ? Life expectancy ? 3months

Exclusion criteria

Exclusion criteria: ? History of receiving iron supplements(oral or intravenous), erythropoiesis-stimulating agents(ESA), tranfusion, hemodialysis within 4 weeks ? Any severe infection within 28 days prior to study start ? Ongoing bleeding ? Bone marrow infiltration by the cancer ? Serum AST and ALT ? 3.5 * upper limit of normal(ULN) ? Hypersensitivity to ferrous sulfate ? Anemia other than iron-deficiency anemia ? Patients with ron overload(Ferritin > 800ng/ml, Transferrin saturation ? 50%) or disorders of iron metabolism ? Pregnancy or Breastfeeding

Design outcomes

Primary

MeasureTime frame
Analysis of the diversity and composition of the gut microbiome by 16S rRNA sequencing—

Secondary

MeasureTime frame
The change of hemoglobin;The mean change of Fe, Ferritin, TIBC;Analysis of the change of gut and systemic metabolome;Treatment-related adverse events graded according to NCI CTCAE version 5.0.;Quality of life assessed by EORTC QLQ-C10—

Countries

Korea, Republic of

Contacts

Public ContactJIWON LEE

Korea University Anam Hospital

jwleemd86@korea.ac.kr+82-2-1577-0083

Outcome results

None listed

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