25 Participants Needed

Examining the Effectiveness of Digestive Enzymes at Reducing Bloating and Stomach Distension

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests Flatter Me, a supplement with digestive enzymes and herbs, to see if it helps people who feel bloated or have indigestion after eating. It compares the effects of Flatter Me by looking at how people feel and measuring their waist size after a meal.

Will I have to stop taking my current medications?

If you are currently taking any prescribed medication for gut health or fluid balance, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment HUM Flatter Me?

The research emphasizes the importance of patient-reported outcomes, which are measures of how patients feel about their treatment. These outcomes are crucial for understanding the effectiveness of any treatment, including HUM Flatter Me, as they reflect real-world benefits that matter to patients.12345

Is the treatment known as HUM Flatter Me generally safe for humans?

The safety of a treatment is often evaluated through adverse event data collected from various sources, including databases like MetaADEDB and post-market surveillance. While specific safety data for HUM Flatter Me is not provided, these systems help track and assess the safety of treatments in humans.678910

How does the drug HUM Flatter Me differ from other treatments for Gorham-Stout disease?

Gorham-Stout disease is a rare condition with no standard treatments available. The research does not provide specific information about HUM Flatter Me, but it highlights the potential for targeting molecular pathways involved in bone cell defects as a novel approach for treatment.1112131415

Research Team

CH

Christopher Hill, PhD

Principal Investigator

Citruslabs

Eligibility Criteria

Inclusion Criteria

Self Report bloating or stomach distension at least once per day after eating

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take either the Flatter Me product or a placebo and eat a test meal to assess changes in bloating and stomach distension

1 week
2 visits (in-person, 1 week gap between visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

  • HUM Flatter Me
Participant Groups
1Treatment groups
Experimental Treatment
Group I: HUM Flatter MeExperimental Treatment1 Intervention
Come to Citruslabs Office twice (1 Week Gap Between Visits) Visit 1: Take Placebo or Test Product; Eat Test Meal; Outcome Measures Visit 2: Take Placebo or Test Product; Eat Test Meal; Outcome Measures

Find a Clinic Near You

Who Is Running the Clinical Trial?

HUM Nutrition, Inc.

Lead Sponsor

Trials
2
Recruited
140+

Citruslabs

Industry Sponsor

Trials
94
Recruited
5,100+

Findings from Research

The definition of an adverse drug event (ADE) should be tailored to the specific purpose of the evaluation, with stricter definitions needed for scientific studies and more flexible ones for clinical use.
Postmarketing safety data for drugs is limited at launch, but can be supplemented through systems like the FDA's Spontaneous Reporting System and targeted research projects, emphasizing the importance of robust epidemiological evidence for regulatory actions like drug recalls.
Adverse drug events: identification and attribution.Rogers, AS.[2022]
MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.
The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.
MetaADEDB 2.0: a comprehensive database on adverse drug events.Yu, Z., Wu, Z., Li, W., et al.[2021]
The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.
By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.
Post-market surveillance of consumer products: Framework for adverse event management.Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

References

Our Measure of Medical Research Should Be Appreciable Benefit to the Patient. [2020]
Measuring postoperative recovery: what are clinically meaningful differences? [2015]
Measuring outcomes in trials of interventions for people who self-harm: qualitative study of service users' views. [2021]
Guidelines for Proper Reporting of Clinical Significance, Including Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, Substantial Clinical Benefit, and Maximal Outcome Improvement. [2023]
Outcomes research in facial plastic surgery: a review and new directions. [2022]
Adverse drug events: identification and attribution. [2022]
MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]
Post-market surveillance of consumer products: Framework for adverse event management. [2022]
A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
I branching formation in erythroid differentiation is regulated by transcription factor C/EBPalpha. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Dysregulated miRNAs in bone cells of patients with Gorham-Stout disease. [2021]
MHC class II transactivator negatively regulates RANKL-mediated osteoclast differentiation by downregulating NFATc1 and OSCAR. [2010]
14.United Statespubmed.ncbi.nlm.nih.gov
The suppressive effect of myeloid Elf-1-like factor (MEF) in osteogenic differentiation. [2008]
15.United Statespubmed.ncbi.nlm.nih.gov
RANK- NFATc1 signaling forms positive feedback loop on rank gene expression via functional NFATc1 responsive element in rank gene promoter. [2021]
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