Butyrate Yogurt for Cancer Constipation

Официальное название

A Phase II Study on the Efficacy and Safety of Butyrate-Containing Short-Chain Fatty Acid Yogurt in Constipation in Patients With Gastrointestinal Malignancies

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Efficacy rate for constipation [Срок оценки: From enrollment to the end of treatment at 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07723729 · TJMUCH-GI-ST03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗