150 Participants NeededMy employer runs this trial

Digestive Enzyme Blend for Abdominal Bloating

MD
Overseen ByMegha Doshi, MD

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?

AM

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

Screening score of >= 55 on the PROMIS Scale v1.1 - Gastrointestinal Gas and Bloating 13a scale
In good general health at the time of screening (Investigator discretion)
Able to read and understand English and provide informed consent
See 8 more

Exclusion Criteria

I am currently in therapy for my digestive or gut-related symptoms.
I have used GLP-1 agonist medications in the past 90 days.
I am currently using or planning to use digestive enzyme supplements.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Arm AActive Control1 Intervention
Group II: Arm BPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kiwi Health Inc

Lead Sponsor

People Science, Inc.

Industry Sponsor

Trials
7
Recruited
730+

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.

A 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.