Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07354100
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lactulose — DRUG
    Lactulose 10 g daily with standard-of-care Immune checkpoint inhibitors (ICIs).

Study Details

The purpose of this study is to see if lactulose can improve the effectiveness of immunotherapy in patients with advanced cancer.

Key Dates

Start date
Dec 15, 2026
Status verified
Jan 2026
Primary completion
Apr 13, 2029
Completion
Apr 13, 2029

Study Design

Enrollment
55 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Arm
    Patients with solid tumor cancers receiving routine immunotherapy will be enrolled to receive lactulose (10 mg daily).
  • Experimental: Phase 2 Arm
    o Patients with melanoma receiving routine immunotherapy will be enrolled to receive lactulose (10 mg daily).

Primary Outcome Measure

Phase 1- [ Time Frame: Baseline to week 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-

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