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NCT Number: NCT04552418

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

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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Potato starch

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).

Other names: Resistant starch

Primary outcomes

  1. Number of patients able to adhere to resistant starch (RS) supplement schedule

    Time frame: Approximately 13 weeks

    Feasibility will be determined by calculating the number of patients who have taken 70% or more of scheduled dose of dietary intervention. Patients will be asked to record doses of starch taken and will be provided a table in which doses can be checked off.

  2. Frequency of serious adverse events (SAEs) attributable to ICI therapy

    Time frame: Up to 6 months (3 months after RS supplement discontinuation)

    Adverse events will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency of known serious effects of ICIs will be compared to historical rates.

  3. Occurrence of unanticipated serious adverse events (SAEs)

    Time frame: Approximately 13 weeks

    Adverse events will be assessed using the NCI CTCAE, version 5.0.

Secondary outcomes

  1. Incidence and severity of immunotherapy-induced diarrhea/colitis

    Time frame: Up to 6 months (3 months after RS supplement discontinuation)

    Graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

  2. Change in luminal microbiome composition

    Time frame: Up to 6 months (3 months after RS supplement discontinuation)

    Weekly stool samples will be compared to the baseline sample (prior to starting starch-based dietary supplement). Stool samples will be analyzed for microbial nucleic acids to characterize the components of the stool microbiome.

  3. Change in luminal microbiome metabolite

    Time frame: Up to 6 months (3 months after RS supplement discontinuation)

    Weekly stool samples will be compared to the baseline sample (prior to starting starch-based dietary supplement). Key metabolic byproducts will be identified in stool specimens using liquid chromatography and mass spectrometry.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 17, 2020
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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