CompletedNot Applicable

Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

United States40 participantsStarted 2021-02-19

Plain-language summary

The purpose of this study is to see whether hematopoietic stem cell transplant (HSCT) patients can consistently eat a diet rich in prebiotics. This type of diet may be helpful in maintaining diversity in the gastrointestinal (GI) system and therefore potentially decreasing risk of other GI problems.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration
✓. Adults (≥18 yrs of age)
✓. Able to provide informed consent
✓. Are willing/able to incorporate the required foods in their diet
✓. Eligible, suitable and planning to undergo a stem cell transplant:
✓. Either allogeneic or autologous
✓. With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning)
✓. Matched related, matched unrelated, haplo-identical and cord blood transplants will be included.

Exclusion criteria

✕. Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant.
✕. Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT)
✕. Patients with any prior history of C.Diff infection

What they're measuring

Frequency of participants ingesting the required diet

Timeframe: From initiation of conditioning regimen for HSCT through 100 days following HSCT

Trial details

NCT IDNCT04629430

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-28

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