An Open-Label Pilot Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
研究概览
简要总结
The goal of this trial is to evaluate the safety and tolerability of an 8-week, multi-component nutritional supplement (AV1PD1A) in adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO).
The main questions the study aims to answer are:
- Is the product safe and well-tolerated over 8 weeks, as measured by bloodwork, vital signs, and adverse effects?
- How many participants adhere to the intervention without a dose modification, hold, or discontinuation?
Exploratory questions include: do GI symptoms and quality of life ratings improve, and do hydrogen/methane levels on lactulose breath testing change from baseline to week 8?
There is no comparison group; this is a prospective, open-label, single-arm pilot trial (n=10).
Participants will:
- Be screened and confirmed to have hydrogen-dominant SIBO by lactulose breath test (with 24-hour prep diet and overnight fast).
- Take AV1PD1A, three capsules daily for 8 weeks.
- Attend three clinic visits at baseline, week 4, and week 8 for vital measurements, fasting blood draws, and adverse event checks.
- Complete questionnaires on symptoms and quality of life.
- Repeat the lactulose breath test at week 8 to assess changes in hydrogen and methane.
详细描述
Prospective, single-site, open-label, single-group pilot conducted at NUNM's Helfgott Research Institute (Portland, OR). The investigational product (AV1PD1A) is a multi-component dietary supplement containing Saccharomyces cerevisiae fermentate (EpiCor), N-acetyl-glucosamine, Saccharomyces boulardii, Lactobacillus rhamnosus (heat-killed), methylcobalamin, berberine, and gingerol (ginger extract). Dosing: 3 capsules daily for 8 weeks. Primary outcome is safety/tolerability (labs, vitals, AEs). Exploratory outcomes include validated PROMIS instruments, IBS Adequate Relief, and changes in lactulose breath-test hydrogen/methane. Enrollment is single-arm with anticipated n = 10 (pilot) to establish feasibility/tolerability signals that inform future powered trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Adults ≥ 18 years.
- •Meets North American Consensus criteria for hydrogen-dominant SIBO by lactulose breath test.
- •Willing to: take study supplement (3 caps/day for 8 weeks); complete two lactulose breath tests with required prep/fast; undergo three fasting blood draws; complete questionnaires.
- •Able to provide informed consent and communicate in English.
- •Individuals of child-bearing potential agree to use effective contraception during the study.
排除标准
- •Recent antibiotics/antifungals/supplements that confound breath test results (e.g., antibiotics within 14 days before breath test; current systemic or topical antifungals).
- •Recent changes in diet/medications/supplement regimen within 30 days.
- •Hospitalization within past 3 months.
- •Allergy/intolerance to product components (e.g., Saccharomyces, Lactobacillus, shellfish [for N-acetyl-glucosamine], ginger, or berberine).
- •Renal/hepatic abnormalities at screening (e.g., eGFR <60 mL/min/1.73 m2; AST/ALT/bilirubin outside of normal reference ranges).
- •Hepatitis from any cause; excessive alcohol use (>7 drinks/week women; > 14 drinks/week men).
- •Medications with concerning interactions after clinical investigator review
研究组 & 干预措施
AV1PD1A
Multi-component dietary supplement taken 3 capsules daily for 8 weeks
干预措施: AV1PD1A (Dietary Supplement)
结局指标
主要结局
Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
时间窗: From baseline/enrollment to the end of treatment at 8 weeks
The number of participants experiencing ≥1 treatment-emergent AE from first dose through end of treatment. Severity graded using CTCAE v5.0 (scale 1-5; 1 is least severe, 5 is most); relatedness assessed by the investigator. Report number of participants with any treatment-emergent AE and summarize by worst grade and relatedness.
Number of participants with laboratory abnormalities meeting pre-specified hold/stop criteria
时间窗: Screening/baseline, Week 4, and Week 8
Count of participants who meet any lab-based stopping rule (e.g., ALT/AST ≥3× ULN, total bilirubin ≥2× ULN, ALP ≥2× ULN with cholestatic pattern, eGFR \<60 mL/min/1.73 m² on repeat or ≥50% decline from baseline, ANC \<1,000/µL, Hgb \<8 g/dL, platelets \<50,000/µL). ULN/LLN per local lab report.
Number of participants requiring any dose modification/temporary hold/discontinuation
时间窗: From first dose (Week 0) through end of treatment at Week 8.
Count of participants who undergo a dose reduction, temporary hold, or permanent discontinuation of the study product per the prespecified dose-modification algorithm (triggered by AEs or labs).
Change in Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 domain T-scores
时间窗: From baseline/enrollment to the end of treatment at 8 weeks
T-scores range from 22.5 minimum to 79.4 maximum. For symptom domains (e.g., Pain Interference, Anxiety, Depression, Fatigue, Sleep Disturbance), higher scores = worse symptoms; for function domains (Physical Function; Ability to Participate in Social Roles and Activities), higher scores = better function. Outcome is a mean change from baseline to Week 8 for the specified single domain.
次要结局
- Change in 0-90-minute hydrogen rise (ppm) on lactulose breath test(From baseline/enrollment to the end of treatment at 8 weeks)
- Change in PROMIS® Gastrointestinal Belly Pain Short Form 6a T-score(From baseline/enrollment to the end of treatment at 8 weeks)
- IBS-Adequate Relief (IBS-AR)(From baseline/enrollment to week 4, to the end of treatment at 8 weeks.)
- Change in PROMIS Gastrointestinal Gas & Bloating Short Form 6a T-score(From baseline/enrollment to the end of treatment at 8 weeks)
- Change in peak methane (ppm) on lactulose breath test(From baseline/enrollment to the end of treatment at 8 weeks)
- Number of participants with a negative lactulose breath test at Week 8(Week 8)
研究者
Brice Thompson
Principal Investigator
National University of Natural Medicine