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Effect of antibiotics on outcomes after hematopoietic cell transplantation

Impact of peri-transplant antibiotics on gut microbiome diversity and hematopoietic cell transplant outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/08/035684
Enrollment
75
Registered
2021-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism Health Condition 2: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue

Interventions

None listed

Sponsors

Division of Nutrition ICMR New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients receiving allogeneic transplantation for any etiology 2. Patients receiving either myeloablative (MAC) or reduced-intensity conditioning (RIC) 3. Patients receiving autologous transplantation (these will be the controls for the allogeneic group)

Exclusion criteria

Exclusion criteria: Patients not consenting to participate

Design outcomes

Primary

MeasureTime frame
To study the association of gut microbiome diversity and microbial-derived metabolites on the following HCT outcomes (a) incidence of infections as measured by incidence of drug resistant bacteremia and/or clostridium difficile associated diarrhea (CDAD) (b) incidence of grade II-IV acute graft versus host disease (GVHD) (c) Survival outcomes as measured by non-relapse mortality (NRM), overall survival (OS), GVHD-/relapse-free survival (GFRS)Timepoint: To study the association of gut microbiome diversity and microbial-derived metabolites on the following HCT outcomes (a) incidence of infections as measured by incidence of drug resistant bacteremia and/or clostridium difficile associated diarrhea (CDAD) (b) incidence of grade II-IV acute graft versus host disease (GVHD) (c) Survival outcomes as measured by non-relapse mortality (NRM), overall survival (OS), GVHD-/relapse-free survival (GFRS)—

Secondary

MeasureTime frame
To study the effect of peri-transplant antibiotics use on the fecal gut microbiome diversity and microbial-derived metabolites as measured by (a) urinary 3-indoxyl sulfate (b) stool short-chain fatty acids (SCFA)(acetic acid, propionic acid, and butyric acid)Timepoint: 30 days—

Countries

India

Contacts

Public ContactShaweta

Postgraduate Institute of Medical Education and Research, Chandigarh

lad.deepesh@pgimer.edu.in9417770112

Outcome results

None listed

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