Butyrate Yogurt for Cancer Constipation

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07723729
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Constipation
  • Gastrointestinal Cancer

Eligibility Criteria

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

Interventions

  • butyrate-containing short-chain fatty acid yogurt — DIETARY_SUPPLEMENT
    Eligible constipated patients were treated with butyrate-containing short-chain fatty acid yogurt

Study Details

Constipation is a common yet underrecognized supportive care issue in cancer patients. Its consequences extend beyond physical discomfort to include impaired quality of life, reduced opioid adherence leading to inadequate analgesia, and increased risks of fecal impaction, emergency visits, and hospitalization. Current management strategies-including laxatives, stool softeners, prokinetics, and PAMORAs-remain suboptimal due to limited effects on gut dysbiosis, mucosal barrier dysfunction, and chronic inflammation, as well as issues related to polypharmacy, variable efficacy, and long-term tolerability. Hence, there is a clear need for novel, well-tolerated, long-term interventions with nutritional benefits that target the gut microbiota-mucosal barrier-motility axis. Short-chain fatty acids (SCFAs), particularly butyrate, are key microbial metabolites that may improve constipation through multiple mechanisms: enhancing intestinal motility via enteric nervous system regulation, reinforcing mucosal barrier integrity and mitigating low-grade inflammation, and restoring gut microbial-metabolite homeostasis. Butyrate supplementation therefore holds mechanistic promise for cancer-related constipation. The "Small Blue Can High Dietary Fiber Butyrate SCFA Yogurt" (Blueglass) is designed with a "probiotics + prebiotics + acids" synergistic fermentation platform, delivering ≥70 mg/100 g butyrate combined with high dietary fiber. Compared with conventional laxatives or single-agent butyrate, this yogurt-based formulation offers potential advantages in patient acceptability, long-term adherence, dual exogenous and endogenous SCFA support, and multi-target action on motility, microbiome, and barrier function, making it a promising candidate for supportive care in this population.

Key Dates

First listed
Jul 23, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group receiving butyrate-enriched short-chain fatty acid yogurt

Primary Outcome Measure

Efficacy rate for constipation [ Time Frame: From enrollment to the end of treatment at 6 weeks ]

Central Contacts

Related Studies