- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07723729
Butyrate Yogurt for Cancer Constipation
A Phase II Study on the Efficacy and Safety of Butyrate-Containing Short-Chain Fatty Acid Yogurt in Constipation in Patients With Gastrointestinal Malignancies
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Tao Ning
- 전화번호: +8613821828358
- 이메일: ningtao37@163.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Treatment group receiving butyrate-enriched short-chain fatty acid yogurt
|
Eligible constipated patients were treated with butyrate-containing short-chain fatty acid yogurt
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Efficacy rate for constipation
기간: From enrollment to the end of treatment at 6 weeks
|
From enrollment to the end of treatment at 6 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TJMUCH-GI-ST03
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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