Is It Worth Trying IBgard?
If you suffer with the cramping, bloating and pain of irritable bowel syndrome (also called irritable bowel disease), you know how frustrating it is to have symptoms with no known cause and few effective treatments.
The unpredictable bowel movement urgency, and intermittent diarrhea and constipation can be a terrible drain on your quality of life, and often nothing but time seems to remedy an IBS flare.
Your doctor might have suggested that you avoid certain foods, increase your fiber (or decrease it) and up your fluids, get plenty of sleep and exercise, and reduce stress.
You may have even been prescribed an antibiotic, or a drug like Viberzi or Linzess to relax the colon or increase the fluid secretion in your small intestine.
But these drugs have risks and (sometimes serious) side effects, and may not provide relief.
But what if none of these lifestyle and medical interventions have been successful?
IBgard – What is It?
If you’ve found yourself researching natural and over-the-counter IBS remedies, chances are, you’ve heard about IBgard.
IBgard is classified as a “medical food” (more on that later) specially formulated for the dietary management of IBS.
IBgard capsules contain individually, triple-coated, sustained-release microspheres of Ultramen, an ultra-purified peppermint oil.
In a recent randomized, multi-centered, double-blind, placebo-controlled trial, IBgard was proven effective, and shown to start working in as early as 24 hours, and this benefit grew when measured at 4 weeks.
This landmark trial included about half the patients diagnosed as having the IBS-M (Irritable Bowel Syndrome-Mixed) subtype. This IBS-M subtype is estimated to represent the majority of IBS sufferers and for which there is no approved product.
IM HealthScience (IMH) was founded in 2012 by a group of senior pharmaceutical executives as a science driven and patient centric company.
Their stated mission is to research, develop and make available state of the art medical foods for gastrointestinal conditions such as Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD).
“MH is a family company rooted in the all too forgotten adage that the patient comes first and doing the right thing will always win out in the long term.
As a small, private organization, IMH is committed to putting patients before profits. IMH is also committed to bringing cutting edge life science and world class clinical research to the medical foods industry.”
Peppermint Oil An Effective Remedy
For centuries, peppermint oil has been used (and is) a well-studied ingredient—with 11 studies published in peer-reviewed medical publications throughout the past decade.
A meta-analysis published in the BMJ (formerly the British Medical Journal) reviewed 12 studies, and confirmed peppermint oil as an effective treatment for irritable bowel syndrome.
A New Delivery System
Dr. Michael Epstein—MD, FACG, AGAF, Chief Medical Advisor of IM HealthScience, Founder and Principle Physician of Digestive Disorders Associates, and President of the Maryland Diagnostic & Therapeutic Endo Center, explains the history leading up to the discovery and making of IBgard:
“There are many patients who suffer from IBS. Some of the treatments have been around for a long time. But there was still a tremendous need to treat this condition.”
IBS is the number one reason that patients will visit a gastroenterologist, according to Epstein.
IM HealthScience took our current scientific knowledge of peppermint oil one step further.
IBgard has been developed using breakthrough science that enables peppermint oil including its primary ingredient, (l-Menthol) to be delivered to the small intestine – the primary site of disturbance in Irritable Bowel Syndrome (IBS).
“IM HealthScience developed very specific technology to turn the liquid peppermint oil into a solid, which was a lengthy and difficult process,” said Epstein.
“The peppermint oil as it existed before is primarily a liquid in a capsule, which would dose-dump into the stomach—this led to heartburn.”
Peppermint, “Dose-Dump,” and Heartburn
In order to help to normalize the digestion of food and the absorption of nutrients, peppermint oil needed to be released slowly and carefully and, ultimately, to bypass the stomach.
More specifically, it needed to be delivered to the small bowel where there is an unmet nutritional need in IBS.
“The formulation of IBgard is very unique,” said Epstein.
“It’s a modern version of peppermint oil: it’s a highly purified peppermint oil that is flash-steamed processed right in the field and is only sourced from one place. So, it has a high content of L-menthol”.
IBgard is a unique formulation of ultra-purified peppermint oil.
Over-the-Counter Peppermint Oil
“The peppermint oil that you can buy over-the-counter comes typically as capsules or gel caps that are subject to unpredictable dosing delivery.
As a result, patients who have early release of peppermint oil can experience heartburn and dyspepsia, while patients who have later release can experience anal burning and lower gastrointestinal symptoms.
“It’s really the [IBgard] delivery system that is designed to get the peppermint oil out of the stomach and into the small intestine where it is PH-released and where, we believe, it is having its primary effect,” says Brooks Cash, MD, of the University of South Alabama in Mobile, who presented the information at presentation at the Digestive Disease Week annual meeting a few years ago.
IBgard is the first product that uses a technology called Site Specific Targeting (SST), which “delivers sustained released microspheres of an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions helps manage IBS,” according a recent press release by IM HealthScience.
Triple-Coated, pH-Triggered Capsules
IBgard is essentially microcapsules within a capsule that bypass the stomach (the pylorus).
Inside each microcapsule, there is a triple coat around the bead—each of which measures 1.2 mm.
The first layer is a non-muco layer (as the outer most coat). This is followed by a middle coat that’s pH-triggered. The inner seal coat is what traps in the peppermint oil.
“These are complicated microbeads,” said Epstein. “I haven’t seen anything this good at getting a drug to a gut. There are other delivery systems, but they are not as sophisticated as this.”
Each IBgard capsule contains 90 mgs of ultra-purified peppermint oil.
Other ingredients are microcrystalline cellulose, gelatin, methacrylic acid copolymer, hypromellose, methycellulose, triethyl citrate, polysorbate 80, FD&C Yellow#5, and FD&C Green#3.
Putting IBgard to the Test
To better understand the processes of IBgard, a 4-week, randomized, placebo-controlled, double-blind clinical trial was done.
The IBSREST™ study was intended to demonstrate whether IBgard would be both safe and effective to normalize the digestion of food and absorption of nutrients, which have been compromised by IBS.
Only patients with more severe IBS were included in this study.
The primary endpoint was the decrease in total symptoms at 28 days compared to baseline.
IBS Symptoms Addressed in the Study
The following symptoms were rated, acting as the main measure of efficacy in the Total IBS Symptoms (TISS) score:
- Abdominal pain
- IBSM (IBS with both constipation and diarrhea)
- Pain at evacuation
- Incomplete evacuation
Clinical Study Results
According to the findings of the study, in as little as 24 hours –
IBgard significantly reduced symptoms of IBS, and the effect continued to improve—with additional symptom reduction at 4 weeks.
There was also a follow-up, real-world, observational study, called the IBSACT study, which found that 60.8 percent of patients with IBS taking IBgard were able to experience relief from IBS symptoms through the consumption of 1 to 2 capsules per day.
IBgard’s Medical Food Classification
“In order to be a medical food, it has to be generally recognized as safe.
There is a specific pathway for medical foods—that’s called the section 5(b)(3) of the Orphan Drug Act. There is a very specific definition for what a medical food is.”
“Medical foods are distinguished from foods that make health claims because they are intended to meet distinct nutritional requirements, used under medical supervision, and attended by a physician to manage the risk of a disease or condition,” explained Epstein. “Therefore, medical foods are specifically formulated and processed, as opposed to naturally occurring.”
Like all medical food products, IBgard does not require prior approval from the FDA. However, even food products can be unsafe if used improperly. IBgard is a medical food and must contain ingredients that are Generally Recognized as Safe (GRAS) or are approved food additives.
IBgard Side Effects
Compared to other treatments for IBS, researchers have found very few side effects with IBgard.
The study concluded that sustained release peppermint oil was “well tolerated with few adverse events.”
IBgard Attains 2018 Symbol of Distinction
IBgard recently gained the Canadian Digestive Health Foundation’s CDHF Certified Symbol of Distinction designation, which indicates that:
The Foundation acknowledges the efficacy and safety of IBgard for helping in the relief and improvement of IBS symptoms, including abdominal pain within 24 hours.
CDHF is the Foundation of the Canadian Association of Gastroenterology (CAG).
For every product bearing the CDHF Certified Symbol of Distinction, the CDHF conducts an independent, peer-reviewed assessment of the body of evidence associated with the constituent of a specific product that claims to elicit a specific outcome.
The CDHF Certified Symbol of Distinction designation indicates independent, peer-reviewed assessment which confirms safety and efficacy of IBgard for Irritable Bowel Syndrome (IBS) symptoms.
This is a significant distinction, since Canada has one of the world’s highest rates of IBS, with five million Canadians sufferers, and 120,000 developing this disorder each year; IBS affects an estimated 13-20 percent of Canadians at any given time.
During a flare of IBS symtoms, take 2 capsules 3 times per day for 4 weeks.
For daily proactive support, take 2 capsules once per day.
When the capsules are taken 30-90 minutes before meals, IBgard starts to relieve IBS symptoms in as little as 24 hours.
Many physicians, in fact, recommend taking IBgard daily, so that IBS relapses and flares can be reduced in severity (or maybe even avoided).
Never crush or chew the capsule or its microshperes; swallow the capsules whole, or mix the microspheres with applesauce (but don’t chew them).
IBgard is not generally covered by health insurance.
Manufacturer Contact Information
IBgard is a non-prescription, over-the-counter remedy, and can be found at drugstores, pharmacies, and online.
IBgard has over 600 reviews on Amazon, and 40 answered questions.
The reviews include many 5 star ratings and, for the most part, are extremely positive. A relatively small number of users found that IBgard didn’t work for them.
Irritable bowel syndrome is a highly complex disease and every individual who suffers from it has a different combination of symptoms, triggers and level of severity.
So it makes sense that not everyone will find relief from the same lifestyle change, prescription or remedy.
Sometimes, it takes a combination of factors to find that “sweet spot” of IBS management, where you can feel confident about preventing, or at least minimizing flares.
IBgard is a relatively new over-the-counter treatment which has been proven to offer relief of IBS symptoms, both in clinical trials and anecdotally. So, if you’re looking for something new to take for your IBS discomfort, give IBgard a try.
Let’s help each other out: please share your tips for coping with IBS below.
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