Effects of Prebiotics on Gut Microbiome in Patients Undergoing HSCT

Multiple Myeloma Clinical Trial

— HCTDiet  

Official title:

Effects of Prebiotics on Gut Microbiome in Patients Undergoing Stem Cell Transplants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04629430
• Other study ID #: HSR 200296
• Status: Completed
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: January 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Maintaining gastrointestinal (GI) microbiome diversity has been shown to improve treatment related mortality in HSCT patients. Interventions to improve GI microbial diversity could be beneficial to this patient population. Diets rich in prebiotics have been shown to increase gut microbial diversity and improve symptoms in other gastrointestinal diseases. Prebiotics are non-digestible carbohydrates that promote growth of commensal organisms in the gut by providing nutrition. Some examples are brown rice, green apples, and tomatoes. Our theory is that consuming a diet rich in prebiotics pre- and during the first 100 days following HSCT will help to reduce acute graft versus host disease (aGVHD) overall, and specifically acute GI GVHD, and clostridium difficile (C.Diff). Participants will be encouraged to eat at least 2 servings of a prebiotic-rich food from time of admission for HSCT through 100 days following HSCT and will be clinically monitored, including for acute GVHD, acute GI GVHD and C.Diff. Stool samples will be collected from all participants about once every 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Agreement to adhere to Lifestyle Considerations(prebiotic diet) throughout study duration

2. Adults (=18 yrs of age)

3. Able to provide informed consent

4. Are willing/able to incorporate the required foods in their diet

5. Eligible, suitable and planning to undergo a stem cell transplant:

1. Either allogeneic or autologous

2. With any conditioning regimen (e.g. both myeloablative and reduced intensity conditioning)

3. Matched related, matched unrelated, haplo-identical and cord blood transplants will be included.

Exclusion Criteria:

1. Patients undergoing a second allogeneic or autologous transplant or an allogeneic transplant after an autologous transplant.

2. Anticipation of requirement of broad spectrum antibiotics 1 week prior to admission for HSCT (through HSCT)

3. Patients with any prior history of C.Diff infection

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Lymphocytic Leukemia
• Acute Myeloid Leukemia
• Anemia, Sickle Cell
• Hodgkin Disease
• Hodgkin Lymphoma
• Leukemia
• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Non Hodgkin Lymphoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Sickle Cell Disease

Intervention

Other:
• Pre-biotic foods/drinks
2 servings per day

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of participants ingesting the required diet	Frequency of participants reporting ingesting at least 2 servings of prebiotics on = 80% of study days	From initiation of conditioning regimen for HSCT through 100 days following HSCT
Secondary	Incidence and severity of acute GVHD (aGVHD) and acute GI GVHD	Stage and grade of aGVHD (allogeneic HSCT participants only)	Within the first 100 days following HSCT
Secondary	Incidence of CDiff infection	Number of people diagnosed with CDiff during the time frame	Within the first 100 days following HSCT
Secondary	Patient weight		From initiation of conditioning regimen for HSCT through 100 days following HSCT
Secondary	Number of days to neutrophil engraftment	Absolute neutrophil count >1000 for 1 day or > 500 for 3 consecutive days	From initiation of conditioning regimen for HSCT through 100 days following HSCT