Gut Microbiota And Radiotherapy

Study summary

A pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedStool Collection

The study team can explain what participation involves.

Who it may be forLung Tumor

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 6, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Abramson Cancer Center at Penn Medicine

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Abramson Cancer Center at Penn Medicine
Interventions being studied: Other: Stool Collection

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patient is planned to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC
Age 18 years old or older
Patient capable of giving informed consent

Reasons someone may not be able to joinExclusion criteria

Use of antibiotics, antifungal, antivirals or antiparasitics during the 4 weeks prior to registration
Active infection with oral temperature \>100°F
Use of corticosteroids, methotrexate or immunosuppressive drugs during the 4 weeks prior to registration
Use of chemotherapy during the 4 weeks prior to radiotherapy or during radiotherapy. Chemotherapy cannot begin before the collection of the 30-day post treatment sample (S4).
Confirmed or suspected HIV, HBV or HCV
Chronic constipation (bowel movements less frequent than every other day)
Active uncontrolled gastrointestinal disorders such as inflammatory bowel disease, moderate/severe irritable bowel syndrome, persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium Difficile infection (recurrent) or Helicobacter Pylori infection (untreated)
Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time
Patients on anti-diarrheal medications
Patients on probiotics

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 6, 2020. Always confirm current availability with the study team.

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