Digestive Enzyme Blend for Abdominal Bloating
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to test a FODMAP-targeting digestive enzyme blend designed to reduce bloating for individuals who often feel gassy or uncomfortable after eating. The enzymes break down certain carbohydrates (FODMAPs) that can cause bloating and stomach pain. Participants will receive either the enzyme blend or a placebo (an inactive look-alike treatment) to compare effects on their symptoms. This study may suit adults who regularly experience bloating and abdominal pain, especially if current diets or treatments are ineffective. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new solutions for digestive discomfort.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not use any other digestive enzymes and avoid medications with substantial gastrointestinal side effects. You should also not change your use of probiotics, fiber supplements, laxatives, or antidiarrheals in the 30 days before starting the trial. If you're on medications that affect your gut, you may need to stop or adjust them, so it's best to discuss this with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the FODMAP-targeting digestive enzyme blend, such as FODZYME®, is generally well-tolerated by individuals with FODMAP intolerances. In one study, 78% of participants reported less bloating after using the enzyme blend for four weeks, indicating its effectiveness and safety. There is no strong evidence of serious side effects. The enzyme blend breaks down FODMAPs, carbohydrates that can cause bloating and gas, providing relief without the strict rules of a Low FODMAP Diet. While individual experiences may vary, the data supports the enzyme blend as a safe option for managing bloating symptoms.12345
Why are researchers excited about this trial?
Most treatments for abdominal bloating focus on symptom relief through dietary changes or medications that reduce gas. However, this new digestive enzyme blend targets FODMAPs—specific carbohydrates that can ferment in the gut, causing bloating. By directly breaking down these troublesome carbs before they cause discomfort, this treatment offers a proactive approach rather than just addressing symptoms after they occur. Researchers are excited because this could provide more effective and faster relief for those struggling with bloating issues.
What evidence suggests that this digestive enzyme blend is effective for abdominal bloating?
This trial will evaluate a FODMAP-targeting digestive enzyme blend for abdominal bloating. Studies have shown that enzyme blends like FODZYME® can significantly improve digestive symptoms. In one study, 72% of participants noticed a clear improvement in their digestive health. Another study found that after four weeks of using this enzyme blend, many people experienced less bloating and stomach discomfort. This enzyme mix breaks down certain carbohydrates (FODMAPs) that can cause gas and bloating before they reach the large intestine. Research suggests this could be an easier option compared to a strict low FODMAP diet, which many find difficult to follow. Participants in this trial will receive both the active enzyme blend and a placebo, allowing for a comprehensive assessment of its effectiveness.12467
Who Is on the Research Team?
Ashley Mateus, Ph.D.
Principal Investigator
People Science
Are You a Good Fit for This Trial?
This trial is for adults who often experience bloating and other gut symptoms, such as those with irritable bowel syndrome (IBS). Participants must self-report regular bloating. People with certain rare conditions or other exclusions may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the active FODMAP-targeting digestive enzyme blend or placebo for 4 weeks, followed by a 2-week washout period, and then crossover to the alternate treatment for another 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FODMAP-targeting digestive enzyme blend
Trial Overview
The study compares a FODMAP-targeting digestive enzyme blend (FODZYME®) to a placebo. Each participant tries both treatments in random order at home, to see if the enzyme helps reduce bloating and related gut symptoms.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kiwi Health Inc
Lead Sponsor
People Science, Inc.
Industry Sponsor
Citations
FODMAP-Targeting Digestive Enzyme Blend for ...
At follow-up, 72% (95% CI: [63.3%, 79.3%]) of participants reported a significant improvement in overall digestive symptoms, as measured by the IBS-SGA.
Research Brief
A prospective 4-week real-world pre–post cohort study (n=118) on FODZYME®, found most participants report clinically meaningful improvements (≥30%) in bloating/ ...
In Vitro Efficacy of Targeted Fermentable Oligosaccharides ...
Our results suggest dietary supplementation with FODZYME would decrease intestinal FODMAP burden and gas production.
4.
ctv.veeva.com
ctv.veeva.com/study/a-study-evaluating-the-impact-of-regular-fodmap-targeting-digestive-enzyme-blend-use-on-gastrointestA Study Evaluating the Impact of Regular FODMAP-targeting ...
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 ...
Digestive Enzyme Blend for Abdominal Bloating
The study compares a FODMAP-targeting digestive enzyme blend (FODZYME®) to a placebo. Each participant tries both treatments in random order at ...
FODMAP-Targeting Digestive Enzyme Blend for Management ...
After 4 weeks using the FODMAP-targeting digestive enzyme blend, 78.0% (95% confidence interval [CI]: [69.7%, 84.5%]) reported improvements in bloating and ...
In Vitro Efficacy of Targeted Fermentable Oligosaccharides ...
Our results suggest dietary supplementation with FODZYME would decrease intestinal FODMAP burden and gas production.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.