A Study Evaluating the Impact of Regular FODMAP-targeting Digestive Enzyme Blend Use on Gastrointestinal Symptoms in Individuals With Self-Reported Bloating
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Bloating Symptoms
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, within-individual crossover trial designed to assess the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend (FODZYME®) on gastrointestinal symptoms in adults with self-reported bloating.1
The study's rationale is based on the fact that fermentable carbohydrates (FODMAPs) are often poorly absorbed and can trigger symptoms like bloating and abdominal pain. While a Low FODMAP Diet (LFD) is clinically validated for symptom relief, it is restrictive. The enzyme blend is intended to offer a more flexible, enzyme-based solution by targeting and breaking down FODMAPs, such as fructan, GOS, and lactose, before they ferment in the colon.
The primary objective is to evaluate the product's impact on bloating symptoms, measured by the mean PROMIS scale Gastrointestinal Gas and Bloating score. Secondary and exploratory objectives include assessing the impact on overall gastrointestinal symptom severity (IBS-SSS), abdominal pain (PROMIS Belly Pain score), food-related quality of life (FR-QoL-29), and anxiety (GAD-7 scores). The study also aims to evaluate these effects across various Irritable Bowel Syndrome (IBS) subgroups (IBS-C, IBS-D, IBS-M). The trial is a consumer-driven, decentralized research study utilizing validated patient-reported outcome measures that can be completed in a home setting.
详细描述
The study product is a FODMAP-targeting digestive enzyme blend designed as a novel, consumer-grade digestive enzyme supplement. Its primary function is to target and break down fermentable short-chain carbohydrates (FODMAPs) in the gut, specifically fructan, Galacto-oligosaccharides (GOS), and lactose, before they can be fermented in the colon.
The product offers an enzyme-based approach to managing symptoms, such as bloating and abdominal pain, which are often triggered by FODMAPs in individuals with Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD), endometriosis, and the broader non-IBS population. This is intended as a more flexible alternative to a Low FODMAP Diet (LFD), which is clinically proven for symptom relief but can be restrictive and difficult to maintain long-term.
Key Characteristics and Use:
Administration: The study product/placebo is to be taken with each meal, snack, or substantial beverage and is applied directly to the food.
Safety and Risk Mitigation: As a digestive enzyme supplement, potential minor risks include temporary gastrointestinal side effects like GI upset, increased gas, or mild changes in bowel habits. To mitigate the risk of allergic reaction, participants with a self-reported known hypersensitivity to corn or previous reactions to digestive enzyme supplements (e.g., Beano and Lactaid) are excluded from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 years old or older
- •Screening score of >= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale.
- •Screening severity score of >= 55 on the PROMIS Scale v1.0 - Gastrointestinal Belly Pain scale.
- •Screening score of <10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- •Adults with or without IBS are eligible; participants with IBS experiencing symptoms must meet the Rome IV criteria as determined by the Rome IV Diagnostic Questionnaire (R4DQ) IBS Module.
- •Able to maintain 80% compliance with daily questionnaires during the 2 week run-in period.
- •In good general health at the time of screening (Investigator discretion).
- •Able to read and understand English and provide informed consent.
- •Able to use a personal smartphone device and download Chloe by People Science.
- •Able to receive shipment of the product at an address within the United States.
- •Able to complete study assessments over the course of up to 19 weeks.
排除标准
- •Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- •Concomitant Therapies:
- •Participants receiving any of the following treatments or therapies are excluded:
- •Any investigational therapies or treatments (pharmaceuticals, devices, supplements) within 30 days prior to randomization.
- •Ongoing psychological therapies specifically targeting gastrointestinal symptoms or functional disorders, including but not limited to GI-directed Cognitive Behavioral Therapy (CBT), GI hypnotherapy, or other therapies for Disorders of Gut-Brain Interaction (DGBI).
- •Treatment with Glucagon-like peptide-1 (GLP-1) agonists (e.g., semaglutide, tirzepatide) within the last 90 days prior to randomization, due to their known effects on gut motility and GI symptoms.
- •Current or recent (within the last 6 months) chemotherapy or immunotherapy for cancer treatment.
- •Current or planned use of any other digestive enzymes prescription or over-the-counter (OTC).
- •Chronic use (defined as daily use for >30 days within the last 90 days) of any medication known to have substantial gastrointestinal side effects (e.g., diarrhea, constipation, nausea) that, in the opinion of the Principal Investigator, may confound the assessment of study outcomes. This may include high-dose NSAIDs, opioids, prokinetics, bile acid binders, or certain antibiotics.
- •Variable use of probiotics, fiber supplements, laxatives, stool softeners, antidiarrheals (if taking) in the last 30 days. Variable use is defined as use of any probiotic, fiber supplement, laxative, stool softener, or antidiarrheal with a dose change greater than 50% in the last 30 days or initiation or discontinuation of a gut-active product in the last 30 days.
- •Other Illnesses or Conditions:
- •Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- •Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder
- •Currently pregnant, planning to become pregnant in the next 4 months, or breastfeeding
- •History of bariatric or other significant gastrointestinal surgery (e.g., small bowel resection, total colectomy) that has permanently altered GI anatomy or function. Standard appendectomy or cholecystectomy are generally permitted.
- •Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes (e.g., Type I diabetes, Endometriosis, etc.).
- •Acute gastroenteritis within the past 4 weeks;
- •New diagnosis workup planned during study that may change diagnosis/ behavior/ medications (eg. colonoscopy prep or major bowel cleanse, upcoming GI consult that could affect eligibility).
- •Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- •Self-reported known hypersensitivity or previous allergic reaction to corn and/or any previous reaction to digestive enzyme supplements (eg. Beano and Lactaid)
- •Comorbid GI conditions: IBD - Ulcerative Colitis or Crohn's Disease, Microscopic Colitis, history of small bowel or colonic surgeries, Celiac disease, or Bile Acid Malabsorption (BAM).
- •Screening score of ≥10 on the Generalized Anxiety Disorder 7-item (GAD-7) scale
- •On a low FODMAP diet based on FODMAP FFQ results at Screening
- •History of following a low FODMAP diet in the past 6 months (self-reported)
- •Any history of following LFD (Low FODMAP Diet) with no response (i.e. failed LFD in past)
- •Participants who are on or plan to initiate a major restrictive or elimination diet, or a structured weight-loss diet, during the study period.
- •No planned changes in diet, lifestyle or medications for IBS during study period.
- •Use of any antibiotics, antifungals, or antivirals within 2 weeks prior to randomization.
- •Participants planning extended travel that would interfere with compliance or study procedures.
- •Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
研究组 & 干预措施
Arm A
Half the participants will start on Arm A. They will use product from Arm A for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm B for the next four weeks.
干预措施: FODMAP-targeting digestive enzyme blend (Dietary Supplement)
Arm B
Half the participants will start on Arm B. They will use product from Arm B for the first for 4 weeks. Then there will be a two week washout and then the participant will use product from Arm A for the next four weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Bloating Symptoms
时间窗: 19 weeks
The Primary outcome will be to evaluate the impact of FODMAP-targeting digestive enzyme blend use on bloating symptoms. This will be done by using the Mean PROMIS scale Gastrointestinal Gas and Bloating score between study product and placebo groups at the end of each study product use period. Scale title: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptoms Scale - Gas and Bloating Scoring: Typically reported as a standardized T-score (reference population mean = 50, SD = 10). Minimum/maximum values: T-scores do not have fixed absolute minimum or maximum values, though scores commonly range approximately from 20-80 in practice. The raw summed score range is 11-55 (11 scored items). Interpretation: Higher scores indicate worse gastrointestinal symptoms (more gas/bloating severity).
次要结局
- Gastrointestinal Symptoms(19 weeks)
- Abdominal Pain(19 weeks)