Randomized, Double-Blind, Placebo-Controlled Trial of De Simone Formulation Probiotic in Patients With Bile Acid Malabsorption/Diarrhea Unassociated With Ileal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in fecal bile acid concentration
研究概览
简要总结
The purpose of this study is to assess effect of the DSF probiotic on fecal bile acid levels in patients with BAM.
详细描述
In this placebo-controlled trial, the De Simone combination probiotic formulation will be tested in 12 patients in each treatment arm. The patient's will be previously diagnosed with bile acid diarrhea. The objective is to assess the effects of this probiotic on fecal blood low acid levels in patients with bile acid diarrhea. Secondary objectives are to evaluate changes in% primary fecal bile acids in a single stool sample, serum 7 alpha C4, intestinal permeability, stool consistency and frequency, fecal short chain fatty acids, and fecal micro biome composition and diversity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior diagnosis of bile acid malabsorption documented in the medical history based on
- •either serum C4 >52.5ng/mL, or
- •fecal 48h total BA excretion >2337 μmol/48h, or
- •primary BA >5% 48h stool collection or >10% in single stool sample.
- •7-day stool dairy with an average stool consistency based on the Bristol Stool Form Scale, BSFS, with a grade greater than
- •Note: If Inclusion criteria 3 is not met, participants may choose to have their blood drawn clinically to further determine eligibility.
- •For women of childbearing potential
- •A negative urine pregnancy test prior to dispensing the study product
- •Agreement to comply with approved methods of contraception during the whole study: unless they meet the criteria of post-menopausal, i.e. 12 months of spontaneous amenorrhea, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, should use one or more of the following acceptable methods of contraception that should be maintained throughout the study:
- •Surgical sterilization
- •Hormonal contraception (implantable, patch, oral, intra-muscular)
- •Intra-uterine device
- •Double barrier method (diaphragm plus condom)
- •At the discretion of the investigator, total abstinence is acceptable in cases where age, career, lifestyle, or sexual orientation of the patient ensures compliance
排除标准
- •Use of oral antibiotics and probiotics within the last 4 weeks.
- •Pregnancy or lactation.
- •Concomitant use of bile acid sequestrants, must stop 10 days before starting 7-day stool dairy and for the duration of the study.
- •History of ileal resection.
- •Diabetes mellitus (type 1)
- •BMI ≥ 40 kg/m^2
- •Diagnosis of gastrointestinal diseases that are associated with inflammation such as inflammatory bowel diseases and celiac diseases or gastrointestinal infection in the prior 4 weeks
- •Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol or could interfere with the study assessments
研究组 & 干预措施
Probiotic Group
干预措施: De Simone formulation probiotic (Dietary Supplement)
Control Group
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in fecal bile acid concentration
时间窗: Baseline, 24 days
Reported as micromoles per g stool and % primary bile acids
次要结局
- Change in intestinal permeability(Baseline, 24 days)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic