Lactulose for Gut Health in Cancer Patients Receiving Immunotherapy
This study is looking at whether taking lactulose, a medication, can make immunotherapy more effective for people with advanced cancer. You might be able to join if you have a confirmed cancer diagnosis and are receiving immunotherapy (like PD-1 or CTLA-4 inhibitors) as your only treatment, without chemotherapy or radiation. The study aims to see if lactulose improves how well your cancer responds to immunotherapy. We don't have information on the current recruitment status, but the study plans to enroll 55 participants.
- Study design
- This is an interventional study planning to enroll 55 participants. It is not specified if it is randomized or blinded.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Overall Response Rate will be measured through study completion, an average of 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07354100
Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of ChicagoInvestigator-initiated
~55 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Lactulose
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1-
Measured over Baseline to week 3
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Daniel Olson · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have a histologically confirmed malignancy that is to receive exclusively ICIs (no chemotherapy or RT in combination) per standard of care during the time in which lactulose will be administered. This includes, but is not limited to, melanoma, cutaneous squamous cell carcinoma, non-small cell lung cancer, mesothelioma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial cancer, MSI/MMRd cancer, cancers with high tumor mutational burden (\>=10 muts/mB), esophageal cancer, hepatocellular carcinoma, and renal cell carcinoma. Anti-PD-1 or anti-PD-L-1 therapy combinations with anti-LAG-3 or anti-CTLA-4 combinations are permitted.
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18 years of age, children are excluded from this study.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Patients must be able to ingest liquids.
Patients must have a histologically confirmed cutaneous or mucosal melanoma. Uveal melanoma is excluded.
Measurable disease per RECIST 1.1.32
Documented primary or acquired resistance to anti-PD-1 and anti-CTLA4 therapy per SITC guidelines.21 Primary resistance is defined as disease progression after a minimum of 6 weeks of therapy, provided the patient has received at least two full cycles of treatment, and there has been no prior evidence of clinical benefit (partial response, complete response, or stable disease lasting at least 6 months). Acquired resistance is defined as disease progression after an initial clinical benefit while still on therapy or within 12 weeks of discontinuing therapy, provided the patient received at least two cycles and 6 weeks of therapy.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Planned to receive standard ICI therapy (no RT/ICI or chemotherapy/ICI combinations).
Age ≥18 years. Because no dosing or adverse event data are currently available on the use of lactulose in combination with ICIs in patients \<18 years of age, children are excluded from this study.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Patients must be able to ingest liquids.
Exclusion
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICIs or lactulose.
Current serious concomitant illnesses include cardiovascular diseases (such as uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmias), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders, including HIV or AIDS-related illnesses or active hepatitis B or C virus.
The ongoing use of systemic antibiotics or the previous use of antibiotics in the 2 weeks before enrollment.
Presence of a chronic intestinal disease (for example, celiac, or malabsorption) where the frequency of bowel movements would interfere with study assessments.
Absence of the large bowel.
The presence of absolute contraindications to lactulose administration includes galactosemia or other conditions that necessitate a low intake of galactose.
Expected to require any other form of systemic anti-neoplastic therapy while in the study (i.e., chemotherapy or radiation therapy).
Symptomatic CNS metastases and/or leptomeningeal involvement. Patients with CNS metastases and/or leptomeningeal involvement may participate if they are clinically stable, as judged by the enrolling investigator.
Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo, type I diabetes, or resolved childhood asthma/atopy are exceptions to this rule.
A history of immune-related adverse events to ICIs that precludes the investigator from comfortably re-challenging with ICIs.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥ 2 years.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ICIs or lactulose.
Current serious concomitant illnesses include cardiovascular diseases (such as uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, and severe cardiac arrhythmias), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders, including HIV or AIDS-related illnesses or active hepatitis B or C virus.
The ongoing use of systemic antibiotics or the previous use of antibiotics in the 2 weeks before enrollment.
Presence of a chronic intestinal disease (for example, celiac, or malabsorption) where the frequency of bowel movements would interfere with study assessments.
Absence of the large bowel
The presence of absolute contraindications to lactulose administration includes galactosemia or other conditions that necessitate a low intake of galactose.
Expected to require any other form of systemic anti-neoplastic therapy while in the study (i.e., chemotherapy or radiation therapy).
Symptomatic CNS metastases and/or leptomeningeal involvement. Patients with CNS metastases and/or leptomeningeal involvement may participate if they are clinically stable, as judged by the enrolling investigator.
Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo, type I diabetes, or resolved childhood asthma/atopy are exceptions to this rule.
A history of immune-related adverse events to ICIs that precludes the investigator from comfortably re-challenging with ICIs.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
What this trial measures
- Phase 1-Baseline to week 3
Change in Bifidobacterium abundance in stool from baseline to week 3.
- Overall Response RateThrough study completion, an average of 2 years
Assessment of cancer response based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1