Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors

NCT ID: NCT04552418

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2023-01-24

Brief Summary

This is a pilot study designed to assess the safety and feasibility of administering a dietary supplement to patients undergoing cancer treatment with a dual immune checkpoint inhibitors (ICIs) for solid cancer.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Potato-based dietary starch supplement

Patients undergoing cancer treatment with dual immune checkpoint inhibitors (ICI) will receive potato-based dietary starch supplements.

Group Type: EXPERIMENTAL

Potato starch

Intervention Type: DRUG

Starting 5-7 days before treatment with dual-ICI, participant will consume 20g of potato starch (Bob's Red Mill®) once a day for 3 days, then increase to 20g twice a day, continuing throughout dual-ICI treatment (total duration approximately 13 weeks).

Interventions

Potato starch

Starting 5-7 days before treatment with dual-ICI, participant will consume 20g of potato starch (Bob's Red Mill®) once a day for 3 days, then increase to 20g twice a day, continuing throughout dual-ICI treatment (total duration approximately 13 weeks).

Intervention Type: DRUG

Other Intervention Names

Resistant starch

Eligibility Criteria

Inclusion Criteria

• Patients starting dual immune checkpoint inhibitor therapy (ipilimumab and nivolumab in any dose combination) for solid cancer treatment per FDA approved indications.
• Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria

• Patients with a history of colectomy and/or gastric bypass.
• Patients with a known diagnosis of inflammatory bowel disease or irritable bowel syndrome.
• Patients with active Clostridium difficile infection. Active infection is defined as a stool sample positive for Clostridium difficile toxin by EIA and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon.
• Inability to take oral supplements
• Patients with existing gastrointestinal symptoms including abdominal pain, diarrhea (watery stool), nausea and/or actively requiring regular anti-emetics.
• Patients with symptomatic bowel metastasis including pain, severe constipation, or gastrointestinal bleeding.
• Receiving antibiotic within 14 days of ICI therapy initiation.
• Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient or raise concern that the patient would not comply with protocol procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Fecher

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00178229

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2020.010

Identifier Type: -

Identifier Source: org_study_id