Butyrate Yogurt for Cancer Constipation

NCT07723729 | Not Yet Recruiting Phase 2

• 1 other identifier: TJMUCH-GI-ST03
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Constipation; Gastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy rate for constipation

  From enrollment to the end of treatment at 6 weeks

Study Arms (1)

Treatment group receiving butyrate-enriched short-chain fatty acid yogurt

EXPERIMENTAL

Dietary Supplement: butyrate-containing short-chain fatty acid yogurt

Interventions

butyrate-containing short-chain fatty acid yogurt DIETARY_SUPPLEMENT

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

Treatment group receiving butyrate-enriched short-chain fatty acid yogurt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Histologically confirmed diagnosis of gastrointestinal malignancy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Confirmed \< 3 spontaneous bowel movements (CSBM) per week during the 1-week baseline period, accompanied by constipation-related symptoms (e.g., straining, hard/lumpy stools, sensation of incomplete evacuation, etc.).
• Anticancer treatment regimen is expected to remain relatively stable during the study period.
• Willing and able to provide written informed consent and complete electronic diary entries.

You may not qualify if:

• Mechanical intestinal obstruction, active inflammatory bowel disease, severe rectal stricture, or acute abdomen.
• Absolute neutrophil count (ANC) \< 1.0 × 10⁹/L or active infection.
• New initiation or major dose adjustment of prosecretory or prokinetic agents within the past 2 weeks.
• Allergy or hypersensitivity to dairy products or any component of the butyrate-containing yogurt formulation.
• Deemed unsuitable for enrollment by the investigator (e.g., poor compliance, cognitive impairment, or other conditions that may interfere with study participation).

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Constipation; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Tao Ning

CONTACT

+8613821828358; ningtao37@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share