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NCT05135351 · ClinicalTrials.gov registry record · NA

Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation

A NA study of Multiple Myeloma and Lymphoma, sponsored by University of Nebraska.

Recruiting
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT05135351 is a NA study of Multiple Myeloma and Lymphoma that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 30 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05135351, a NA study of Multiple Myeloma and Lymphoma, is actively recruiting participants, sponsored by University of Nebraska.

RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell engraftment. To test this, participants will either have RS or a placebo (maltodextrin) mixed into a food item of their choice for approximately 10 days prior to stem cell infusion and continue to the first day of neutrophil engraftment. The study will look at the difference in gut microbiome diversity between the RS and placebo arm collected at the engraftment timepoint, dietary evaluation to assess the impact of subject diet on microbiome response to intervention and serum sample collection to assess differences to gut permeability during transplant.

Interventions

  • DIETARY_SUPPLEMENT Maltodextrin
  • DIETARY_SUPPLEMENT Resistant Starch

Study Locations (1)

Nebraska

  • Unversity of Nebraska Medical Center - Omaha

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-04-13
Est. Completion 2028-07
Phase NA

Sponsor

University of Nebraska

407 total trials

What the Registry Record Tells You About NCT05135351

The ClinicalTrials.gov registry entry for NCT05135351 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (95% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Maltodextrin is the first listed.

NCT05135351 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.

Frequently Asked Questions

What is clinical trial NCT05135351 about?

NCT05135351 is a clinical study titled "Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation". Higher gut microbiome diversity has been associated with improved survival following autologous stem cell transplantation in multiple myeloma and lymphoma. This study hypothesises that prebiotic supplementation with resistant starch (RS) will improve gut microbiome diversity at time of stem cell eng...

What is the current status of trial NCT05135351?

This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-04-13. Estimated completion is 2028-07.

What conditions does trial NCT05135351 study?

This clinical trial studies the following conditions: Multiple Myeloma, Lymphoma.

What interventions are being tested in trial NCT05135351?

The interventions under investigation include: Maltodextrin (DIETARY_SUPPLEMENT), Resistant Starch (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05135351?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05135351 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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