Tributyrin to Promote Gut Health Among Children Undergoing Hematopoietic Cell Transplantation

NCT05951153 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: Pro00112603
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the safety and tolerability of tributyrin among children undergoing hematopoietic cell transplantation (HCT).

Conditions

Hematopoietic Cell Transplantation (HCT)

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of tributyrin among children undergoing hematopoietic cell transplantation (HCT)

  An evaluation of the safety and tolerability of tributyrin.

  36 months

Secondary Outcomes (4)

• Change in fecal butyrate concentration

  Baseline, 36 months

• Change in gut microbiome composition

  Baseline, 36 months

• Change in gut inflammation

  Baseline, 36 months

• Change in gut barrier integrity

  Baseline, 36 months

Study Arms (1)

Tributyrin nutritional supplement

EXPERIMENTAL

Children between the ages of 2-17 with planned allogeneic hematopoietic cell transplantation with myeloablative preparative regimen, who also have standard of care nasogastric tube placement or existing gastric tubes will receive a daily dose of tributyrin.

Combination Product: Tributyrin

Interventions

Tributyrin COMBINATION_PRODUCT

Tributyrin is a nutritional supplement prepared by esterification of glycerin with butyric acid that promotes delivery of free butyrate to distal portions of the gut.

Also known as: Nutritional supplement

Tributyrin nutritional supplement

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-17 years with standard of care nasogastric tube placement or existing gastric tubes
• Planned allogeneic hematopoietic cell transplantation with myeloablative preparative regimen
• Planned graft-versus-host-disease prophylaxis with calcineurin inhibitor + mycophenoalte mofetil or calcineurin inhibitor + methotrexate

You may not qualify if:

• Previous history of hematopoietic cell transplantataion

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

tributyrin; Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 18, 2023
• Study Start: August 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08