What side effects are associated with this type of intervention?

Common treatments for abdominal bloating include probiotics, fiber supplements, and medications like alosetron and lubiprostone. Probiotics are generally well-tolerated but can cause mild gastrointestinal symptoms such as gas and bloating. Fiber supplements, while beneficial for bowel regularity, can initially increase bloating and gas if not introduced gradually. Alosetron, used for IBS, can cause constipation and has a rare risk of ischemic colitis. Lubiprostone, used for IBS with constipation, may cause nausea and diarrhea. Patients should discuss these potential side effects with their healthcare provider to determine the best treatment option.

What prior FDA approvals exist?

The FDA has approved several treatments for abdominal bloating, particularly those targeting gut motility and gastrointestinal symptoms. Notable examples include rifaximin, a nonabsorbed oral antibiotic shown to improve symptoms of irritable bowel syndrome (IBS) without constipation, and lubiprostone, a chloride channel activator used for IBS with constipation. Additionally, guanylate cyclase agonists like linaclotide and plecanatide stimulate intestinal fluid secretion and transit, offering relief for persistent constipation. These treatments align with the goals of the Gut Health Drops trial, which aims to enhance gut motility and alleviate gastrointestinal discomfort.

What other types of research exist?

Promising novel alternatives to Gut Health Drops for treating abdominal bloating include: 1) Gelesis100, a superabsorbent hydrogel shown to aid in weight loss and potentially improve gastrointestinal symptoms; 2) Liraglutide, which has been studied for its effects on gut motility, though it is primarily used for weight management; 3) Soy germ pasta enriched in isoflavones, which has shown potential in improving gastric emptying in diabetic patients with gastroparesis; 4) Lubiprostone, a chloride channel activator that enhances intestinal fluid secretion and has been effective in treating constipation-predominant IBS, which can contribute to bloating.

← Back to Search

ConcenTrace for Gut Health

N/A

Waitlist Available

Research Sponsored by Trace Minerals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial involves participants taking a daily liquid supplement for a few months to improve gut health. It targets individuals looking to enhance their digestion and reduce issues like constipation and bloating.

Who is the study for?

This trial is for men and women over 18 with a BMI under 35 who experience digestive issues like heartburn, gas, or constipation. Participants should be generally healthy without any uncontrolled diseases and willing to keep their diet, activity level, and weight stable during the study.

What is being tested?

The trial is testing ConcenTrace Trace Mineral Drops' effects on gut health over a period of 12 weeks. Participants will take the drops daily and report on various aspects of gut health including bowel movements and bloating at multiple points throughout the study.

What are the potential side effects?

Potential side effects are not explicitly listed but may include changes in digestion or bowel habits due to mineral intake from the drops. Any adverse reactions experienced by participants will likely be monitored through questionnaires.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]

Secondary study objectives

Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]

Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Test arm: ConcenTraceExperimental Treatment1 Intervention

Participants will follow this weekly dosing schedule: Week 1: Day 1-3: take 5 drops of ConcenTrace with 8oz of water or flavored water. Day 4-7: take 5 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 2: Take 10 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 3: Take 15 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 4: Take 20 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Weeks 5 - 12: Take 40 drops of ConcenTrace 1x per day with 8 oz of water or flavored water.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for abdominal bloating include dietary interventions, fiber supplements, and probiotics. Dietary interventions, such as low-FODMAP diets, reduce the intake of fermentable carbohydrates that can produce gas and exacerbate bloating. Fiber supplements, like psyllium, improve stool consistency and promote regular bowel movements, which can alleviate bloating. Probiotics introduce beneficial bacteria to the gut, enhancing gut microbiota balance and reducing gas production. These treatments are important for patients with abdominal bloating as they target the underlying causes of bloating, such as poor gut motility and imbalanced gut flora, thereby improving overall gastrointestinal health and comfort.

Aerophagia and Intestinal Gas.