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A Study on How Gut Bacteria and Body Processes Influence Nausea and Vomiting Caused by Chemotherapy in Stem Cell Transplant Patients

Microbial and metabolic determinants of chemotherapy induced nausea and vomiting :A systems-level multi-omics investigation into gut-derived biological pathways influencing chemotherapy induced nausea and vomiting in stem cell transplant patients-A prospective observational study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/091835
Enrollment
106
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to participate in the study and to provide written informed consent 2. Patients aged 12yrs to 65 yrs. undergoing Conditioning for autologous or allogenic hematopoietic stem cell transplant 3. Weight more than or equal to 30 kg

Exclusion criteria

Exclusion criteria: 1) Hepatic dysfunction (aminotransferase/alanine aminotransferase more than 3 times of upper normal limit, serum bilirubin more than 2 times of upper normal limit) 2) Patients with cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months 3) Preexisting psychiatric disorders 4) Severe renal impairment (GFR less than 50 ml/hr. or creatinine more than 1.5 times upper normal limit) 5) Pregnant or lactating women 6) Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
To find the association between baseline microbiome and chemotherapy induced nausea vomiting in patients undergoing hematopoietic stem cell transplantTimepoint: Baseline and at the end of 6 days from last day of conditioning regimen

Secondary

MeasureTime frame
1. To assess the association between the gut microbiome composition and the metabolomics profile with CINV 2. To evaluate the association between dietary intake and gut microbiome composition with CINV 3. To perform an integrative analysis to explore: The interaction between microbiome, metabolomics, diet and their combined effect on CINV. Timepoint: Baseline

Countries

India

Contacts

Public ContactDr. Deepam Pushpam

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

deepampushpam@gmail.com9650629370

Outcome results

None listed

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