Clinical trial NCT04552418: Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
Official title: Pilot Study of Intestinal Microbiome Modification With Resistant Starch in Patients Treated With Dual Immune Checkpoint Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Solid Tumor
Keywords: Immune checkpoint inhibitor
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of patients able to adhere to resistant starch (RS) supplement schedule
timeFrame: Approximately 13 weeks
measure: Frequency of serious adverse events (SAEs) attributable to ICI therapy
timeFrame: Up to 6 months (3 months after RS supplement discontinuation)
measure: Occurrence of unanticipated serious adverse events (SAEs)
timeFrame: Approximately 13 weeks
Secondary outcomes:
measure: Incidence and severity of immunotherapy-induced diarrhea/colitis
timeFrame: Up to 6 months (3 months after RS supplement discontinuation)
measure: Change in luminal microbiome composition
timeFrame: Up to 6 months (3 months after RS supplement discontinuation)
measure: Change in luminal microbiome metabolite
timeFrame: Up to 6 months (3 months after RS supplement discontinuation)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Leslie Fecher
role: PRINCIPAL_INVESTIGATOR
References: