NCT04171466已完成不适用
A Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy of a Multi-strain Synbiotic (SH-DS01) to Restore Gut Barrier Integrity and Gut Microbiota Composition After Antibiotic Administration.
Seed Health1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年8月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in microbiota composition at 3 months as assessed by whole genome shotgun sequencing.
研究概览
简要总结
In the United States, healthcare providers prescribe over 270 million antibiotic prescriptions each year. While antibiotics have transformed medicine and methods of treating life-threatening bacterial infection, broad spectrum antibiotics also induce disruption of resident gut microbial communities by altering both composition and function. This disruption of microbial community dynamics has been demonstrated at the taxonomic level, yet the extent of functional disruptions to microbial metabolic output and host cells remains understudied in humans. This study explores the impact of a broad spectrum antibiotic cocktail on microbial communities throughout the gastrointestinal tract, and the impact of a defined, multi-strain consortia of probiotic organisms following antibiotic exposure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males & Females 18-55 years of age, inclusive
- •BMI of 18.5 - 29.9 kg/m2, inclusive
- •Waist circumference < 102 cm in males or < 88 cm in females
- •Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months.
- •Healthy as determined by laboratory results, medical history, and physical exam by QI
- •Agrees to abstain from use of fermented foods or beverages with live bacteria or products containing active cultures for the duration of the study
- •Agrees to avoid alcoholic beverages and drugs containing alcohol during antibiotic treatment period and for at least one day after (days 0-8)
- •Agrees to avoid high caffeine intake (no more than 1 cup of coffee or 300 mg of caffeine/day) during antibiotic treatment period of the study (days 0-7)
- •Agrees to refrain from intake of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) during antibiotic treatment period of the study (days 0-7) and 72 hours prior to prior to lactulose and mannitol test
- •Agrees to refrain from using drugs and supplements containing aluminum, magnesium, sorbitol and/or mannitol 72 hours prior to lactulose and mannitol test.
- •Agrees to comply with all study procedures
- •Agrees to maintain current level of physical activity throughout the study
排除标准
- •Women who are pregnant, breast feeding, or planning to become pregnant during the trial
- •Allergy or sensitivity to antibiotics (Ciprofloxacin, Metronidazole), Lactulose or Mannitol, or investigational product's active or inactive ingredients
- •Use of antibiotics or antifungals within three months prior to enrollment, including topical antibiotics or antifungals.
- •Clinically significant abnormal laboratory results at screening as assessed by the QI
- •Use of PPIs and H2-antagonists
- •Use of tobacco products
- •Type I or type II diabetes mellitus or treatment with anti-diabetic medication
- •Unstable metabolic diseases or chronic diseases as assessed by the QI
- •Self-reported current or pre-existing thyroid condition.
- •Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- •Current or history of any significant diseases of the gastrointestinal tract that may impact study outcomes as assessed by the QI
- •Significant cardiovascular event in the past 6 months. If the event occurred greater that 6 months ago and if on stable medication may be included after assessment by the QI on a case by case basis
- •Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI
- •Self-reported an autoimmune disease or an immune-compromised state
- •Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
- •History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months
- •Self-reported medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- •Self-reported blood/bleeding disorder. To be confirmed by the QI on a case by case basis
- •Cancer in the five years prior to enrollment, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable following case by case assessment by QI.
- •Clinically significant illness in the four weeks prior to randomization
- •Current use of prescribed medications listed in Section 7.3.1
- •Current use of over-the-counter medications, supplements, foods and/or drinks listed in Section 7.3.2
- •Current use of any probiotic, prebiotic and symbiotic product unless willing to undergo a 4-week washout and abstain from consuming such products during the study.
- •Medical use of cannabinoid products
- •Use of any cannabinoid products (including synthetics) within one month of study entry
- •Alcohol or drug abuse within the last 12 months
- •High alcohol intake (>2 per day or a total of >10 standard drinks per week)
- •Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
- •Participation in other clinical research trials 30 days prior to screening
- •Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
研究组 & 干预措施
Broad Spectrum Antibiotic Therapy + Microbial Consortia
Active Comparator
干预措施: Ciprofloxacin + Metronidazole (Other)
Broad Spectrum Antibiotic Therapy + Placebo
Placebo Comparator
干预措施: Ciprofloxacin + Metronidazole (Other)
Broad Spectrum Antibiotic Therapy + Placebo
Placebo Comparator
干预措施: Placebo (Other)
No Antibiotic Therapy + Placebo
Placebo Comparator
干预措施: Placebo (Other)
No Antibiotic Therapy + Microbial Consortia
Active Comparator
干预措施: SH-DS01 (Other)
Broad Spectrum Antibiotic Therapy + Microbial Consortia
Active Comparator
干预措施: SH-DS01 (Other)
结局指标
主要结局
Change in microbiota composition at 3 months as assessed by whole genome shotgun sequencing.
时间窗: Baseline- Days 91
Microbiota composition will be identified through fecal samples for total genomic DNA extraction in participants supplemented with SH-DS01 and with or without antibiotics.
次要结局
- Difference in serum LPS-binding protein (LBP) at Day 7.(Baseline- Days 91)
- Difference in the Intestinal Permeability Assessment (IPA) at Day 7 as measured by Lactulose/mannitol testing.(Baseline- Days 91)
- Metabolomic profile of stool samples.(Baseline- Days 91)
- Number of participants with improved Antibiotic-Associated Gastrointestinal Function(Baseline- Days 91)
研究者
研究点 (1)
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