Using prebiotics to enhance gut health after stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether prebiotic supplementation with resistant starch can improve gut microbiome diversity in patients undergoing autologous stem cell transplantation for multiple myeloma or lymphoma. Participants will be randomly assigned to receive either resistant starch or a placebo for approximately 10 days prior to stem cell infusion, continuing until the first day of neutrophil engraftment. The primary goal is to assess differences in gut microbiome diversity at the time of engraftment, alongside dietary evaluations and serum sample collection to analyze gut permeability changes during the transplant process.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Willing to provide informed consent
2. Willing to comply with all study procedures and be available for the duration of the study
3. Has pathologically confirmed multiple myeloma, Non-Hodgkin lymphoma (DLBCL, mantle cell lymphoma, follicular lymphoma, or peripheral T-cell lymphoma), or Hodgkin lymphoma as determined on medical record review per standard of care transplant procedures (no tissue required for study)
4. Meeting a standard-of-care indication for autologous stem cell transplantation for the above diseases as determined by the investigator
5. Adult Individuals (male or female) at least 19 years of age
6. Meeting indications and recommended for first autologous stem cell transplantation by investigator

Exclusion Criteria:

1. History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease
2. Previous intolerance to fiber supplementation
3. Allergy or intolerance to potato starch or maltodextrin
4. Subject unwilling to comply with stool sample collection
5. Not suitable for study participation due to other reasons at the discretion of the investigators

Eligibility Criteria for CAR T-cell Therapy Cohort

Inclusion Criteria:

1. Willing to provide informed consent
2. Willing to comply with all study procedures and be available for the duration of the study
3. Has pathologically confirmed lymphoma or multiple myeloma meeting a commercial indication for CAR-T cell therapy
4. Adult Individuals (male or female) at least 19 years of age
5. Meeting indications and recommended for CAR-T cell therapy by investigator

Exclusion Criteria:

1. History of bariatric surgery (i.e. gastric banding, sleeve gastrectomy, Roux-en-Y bypass), chronic gastrointestinal disease including chronic diarrheal illness or inflammatory bowel disease, or other GI surgery risking diminished effect or tolerance to therapy as determined by investigator
2. Previous intolerance to fiber supplementation
3. Allergy or intolerance to resistant starch or maltodextrin
4. Subject unwilling to comply with stool sample collection
5. Not suitable for study participation due to other reasons at the discretion of the investigators

Where it's running

• Unversity of Nebraska Medical Center
  Omaha, Nebraska, United States Recruiting

Study contacts

• Principal investigator: Christopher R D'Angelo, MD — University of Nebraska
• Study coordinator: Jayson Henrickson, MS
• Email: jayson.henrickson@unmc.edu
• Phone: 402-559-3810

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.