Recruiting

Resistant Starch

Sponsor:

University of Nebraska

Code:

NCT05135351

Conditions

Multiple Myeloma

Lymphoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Resistant Starch

Maltodextrin

Study Details

Brief 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.

Conditions

Multiple Myeloma

Lymphoma

Study ID

NCT05135351

Start date

May 13, 2022

Status verified date

Nov, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment

resistant starch

placebo comparator: Placebo

maltodextrin

Interventions

Resistant Starch

A prebiotic nutritional supplement available at commercial grocery and health food stores. Specifically, we will be using Bob's Red Mill® potato starch.

Maltodextrin

A starch commonly used as a placebo in prebiotic trials that is digested in the stomach and rapidly absorbed

Primary outcome measure

  • Percentage of subjects who adhere to >70% of scheduled doses of the intervention [ Time Frame: 35 Days ]

Central Contacts and Locations

Central contacts

Jayson Henrickson, MS

402-559-3810jayson.henrickson@unmc.edu

Taylor A Johnson, BS, MA

402-559-0963taylora.johnson@unmc.edu

Locations

Unversity of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Christopher R D'Angelo, MD

402-559-8013christopher.dangelo@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Jul 27, 2026

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-07-27.