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Severe IBS Symptoms: Clinical Trial results on delivery of peppermint oil to the small intestine through a system (IBgard®)

https://pharmaceuticalintelligence.com/2015/07/08/severe-ibs-symptoms-clinical-trial-results-on-delivery-of-peppermint-oil-to-the-small-intestine-through-a-system-ibgard/

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 5/10/2017 

Reporter: Gail S. Thornton, MA

Additional Data Analysis from an IBS (Irritable Bowel Syndrome) Clinical Trial Demonstrate IBgard® Delivered Unprecedented Symptom Reduction in the Largest and Most Dissatisfied Group of IBS Patients  

  • Groundbreaking clinical results presented in Chicago at the world’s premier gastroenterology meeting, Digestive Disease Week (DDW), show dramatic symptom reduction among IBS-M (mixed diarrhea and constipation) patients, who experience a high burden in terms of symptoms and quality of life
  • Patients with IBS-M are the most challenging and difficult to diagnose and manage
  • Additional data analysis of only IBS-M patients showed IBgard®, compared to placebo, significantly reduced Total IBS Symptom Score (TISS) and showed favorable effects on all 8 measured individual IBS symptoms, including constipation, diarrhea and abdominal pain

 

CHICAGO – (May 10, 2017) –  The more recent scientific understanding of Irritable Bowel Syndrome (IBS) having multiple causes, including reversible, low-grade inflammation, resulting in abdominal pain, constipation and/or diarrhea in some patients, received further support during Digestive Disease Week (DDW). This is the premier annual meeting of gastroenterologists in Chicago and this subject was discussed on May 9, 2017.

Brooks D. Cash, M.D., A.G.A.F., Professor of Medicine at the University of South Alabama in Mobile, Ala., and Chief of the USA Gastroenterology Division, was the lead presenter of an additional clinical analysis of the IBSREST™ study, a randomized clinical trial (RCT) previously presented at DDW, where IBgard® showed significant efficacy in a combined group of IBS-M (mixed diarrhea and constipation) and IBS-D (diarrhea predominant) patients at 24 hours and at 4 weeks.

Additional analysis of only the IBS-M patients in IBSREST™ demonstrated that there was a statistically significant reduction vs. placebo in the Total IBS Symptom Score (TISS) at 4 weeks. TISS is a composite score of the eight individual IBS symptoms. When evaluating the individual symptoms at 4 weeks, there was a favorable reduction on both major types of bowel dysfunction (diarrhea and constipation) and favorable reduction in viscerosensory symptoms, including abdominal pain and other IBS symptoms.

IBS-M is a challenging and difficult to diagnose and treat sub-type of IBS and represents an area of high unmet need. Most individuals with IBS (74 percent of those medically diagnosed and 63 percent not medically diagnosed) reported variable symptoms of constipation and diarrhea.[1]  There are no FDA-approved interventions for IBS-M.

It has been posited that l-Menthol, the principal component found in IBgard®, works via several different mechanisms of action in the gut, including exerting anti-inflammatory, smooth muscle relaxing and anti-nociceptive effects. Immune-activated gut barrier disturbance in the small intestine is believed to be another possible source of IBS-related altered stool form, as well as abdominal pain and other IBS symptoms.

IBgard® is specially formulated for the dietary management of IBS and is the first product using a patented, breakthrough technology called Site Specific Targeting (SST®) to deliver individually triple-coated, solid-state, sustained release microspheres of Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions help manage IBS.

According to Ali Rezaie, M.D., assistant director, Gastrointestinal Motility Program at Cedars-Sinai Medical Center in Los Angeles, “Alternating bowel habits can happen on a daily basis… Intervals between the patterns [IBS-D and IBS-C] can vary widely.” He added, “I have patients who say they have constipation in the morning, and then, by evening, they have loose watery stools. Even with the same bowel movement, some patients may start with hard stool that has to be pushed, and by the end, it will be watery.”[2]

“Over the last several years, we in the gastroenterology community have tended to bracket IBgard® as an anti-spasmodic for IBS-D, similar to prescription antispasmodics, but with minimal side effects,” said Dr. Cash. “The current findings raise the possibility that there may be broader clinical applications for IBgard® in reducing IBS-M symptoms as well. This is an important observation that needs further research in terms of the most important mechanisms of action of l-Menthol.”

“We are gaining a great understanding of the underlying causation of IBS,” said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®, the innovators of IBgard®. “The largest and most dissatisfied group of IBS patients should start seeing the benefit of recent advances in IBS science.”

Gut Mucosal Barrier Dysfunction Is Key Factor in IBS

As a complex and multifactorial disorder, IBS involves several factors that interact in the body to produce, at various times, digestive tract symptoms, including constipation, diarrhea, bloating, abdominal pain and discomfort.

As new diagnostic tools help advance science in gastrointestinal disorders, gut mucosal barrier dysfunction associated with reversible and low-grade inflammation is now becoming better accepted as a root cause.

Overview of Clinical Sub-Analysis of IBS-M in IBSREST RCT

As mentioned earlier, the IBSREST™ RCT had already shown favorable results in a combined group of IBS-D and IBS-M patients.

In view of the unmet need in IBS-M, researchers performed an additional analysis to test the efficacy of IBgard® in patients with IBS-M in the IBSREST™ study. The analysis showed that in the composite score of all eight symptoms measured, IBgard® demonstrated a significant reduction vs. placebo. It also showed favorable results in individual IBS symptoms, including diarrhea and constipation, where it showed significance (P=0.0085) despite the smaller sample size.

More specifically, the analysis of IBS-M patients in the IBSREST™ study showed that after four weeks of daily intake of IBgard®, patients experienced the following:

Reduction in Total IBS Symptom Score (TISS):

  • 3% reduction of Total IBS Symptom Score (TISS) from baseline. Statistically significant compared to placebo (P=0.0298).
  • 1% reduction in frequency of IBS symptoms from baseline. Statistically significant compared to placebo (P=0.0349).
  • 2% reduction in intensity of IBS symptoms from baseline. Near significance compared to placebo (P=0.0528).

Reduction in Overall Constipation Score:

  • 1% reduction in overall constipation symptoms from baseline. Statistically significant compared to placebo (P=0.0085).
  • 3% reduction in frequency of constipation from baseline. Statistically significant compared to placebo (P=0.0137).
  • 64% reduction in intensity of constipation from baseline. Statistically significant compared to placebo (P=0.0221).

 

Reduction across the Syndrome of Symptoms (abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus):

  • Greater reduction in all eight symptoms of IBS comprising the TISS, compared to placebo, with significance reached in abdominal pain (P=0.0426), constipation (P=0.0085), urgency (P=0.0364), and sense of incomplete evacuation (P=0.0422).
  • The largest reduction was seen with constipation versus placebo (P=0.0085).
  • Numerical reduction versus placebo in both constipation (P=0.0085) and diarrhea (P=0.2296) in IBS-M.
  • Pain at evacuation was numerically superior (P=0.0720).

IBSREST™ Study Design

To qualify for entry in the IBSREST™ study, the participants had to meet Rome III criteria for IBS-M. They had to have average daily IBS-related abdominal pain of ≥ 4 on a 0-10 scale, and a TISS of ≥ 2 on a 0-4 scale.

In the study, there were 34 IBS-M participants, 16 who received IBgard® and 18 who received placebo. Study participants were randomly allocated to receive IBgard® 180 mg TID or identical placebo for four weeks. Primary analysis was based on the TISS score. Additional assessments included change from baseline in frequency and intensity of individual IBS symptoms.

About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, under-diagnosed and under-treated condition characterized by recurrent abdominal pain, often associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS. Recent understanding regarding the multiple etiologies of IBS point to gut mucosal barrier dysfunction associated with reversible, low-grade inflammation as a potential contributor to abdominal pain and altered stool form symptoms of IBS.

About IBgard®  

IBgard® is a medical food specially formulated for the dietary management of IBS. IBgard® capsules contain solid state microspheres of peppermint oil, including its principal component l-Menthol, plus fiber and amino acids (from gelatin protein), in a unique delivery system.

With its patented Site Specific Targeting (SST®) technology, pioneered by IM HealthScience®, IBgard® capsules release Ultramen®, an ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help manage IBS. The food nutrients in IBgard® (peppermint oil along with fiber and amino acids) may help reduce the low-grade, reversible inflammation found in some IBS and help normalize gut mucosal barrier function. Additionally, peppermint oil has also been shown to help normalize intestinal transit time.

IBgard® was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called the Irritable Bowel Syndrome Reduction Evaluation and Safety Trial™ (IBSREST).  Patients suffering from IBS-M and IBS-D were included in the study. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. The data showed that IBgard® demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks. The TISS represents a composite score of eight individual IBS symptoms. Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. In a recent nationwide survey of gastroenterologists, IBgard® is the number one recommended peppermint oil for IBS among gastroenterologists for the second consecutive year by an overwhelming margin. Like all medical foods, IBgard® does not require a prescription, but it must be used under medical supervision. Only doctors can diagnose IBS. The usual adult dose of IBgard® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day.

IBgard® is available to patients in the digestive aisle at most Walmart, CVS/pharmacy, Walgreens and Rite Aid stores nationwide as well as in independent drug stores and grocery stores across the country.

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard® for the dietary management of irritable bowel syndrome. It is a privately held company based in Boca Raton, Florida, that is also the innovator of FDgard® for the dietary management of functional dyspepsia. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com or www.FDgard.com.

Data Presented at DDW Poster Session on Irritable Bowel Syndrome

Tuesday, May 9, 2017

  • (Poster Session #Tu1601) In Patients with Irritable Bowel Syndrome-Mixed (IBS-M), a Novel Peppermint Oil Formulation Designed for Site Specific Targeting (PO-SST), in the Small Intestine, Improves the 8 Symptoms that Comprise the Total IBS Symptoms Score (TISS). 
    • Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
  •  (Poster Session #Tu1600) Patient Responder Analysis for a Total IBS Symptom Score (TISS) and Abdominal Pain with a Novel Peppermint Oil Site Specific Targeting (PO-SST) Formulation from the US-based IBSREST Randomized Controlled Trial
    • Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah

For more information about featured studies, as well as a schedule of availability for featured researchers, please visit www.ddw.org/press.

About Digestive Disease Week® (DDW)

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2017, at McCormick Place, Chicago, IL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

Regulation of Medical Foods

IBgard® is a medical food product and not a drug or dietary supplement.  A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C, 360ee (b)(3) as a “food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinct nutritional requirements, based on scientific principles, are established by medical evaluation.” Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. Medical foods must contain ingredients that are “Generally Recognized As Safe” (GRAS), or are approved food additives, as defined under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act.

REFERENCE/SOURCE

[1] Hungin, A.P.S., Chang, L., Locke, G.R., Dennis, E.H. & Barghout, V. (2005, June 2). Irritable bowel syndrome in the United States: prevalence, symptom patterns and impact. Alimentary Pharmacology and Therapeutics, 21 (11): 1365-1375.  doi: 10.1111/j.1365-2036.2005.02463.x.

[2] Swift, D. & Bilal, M. (2016, December 15). IBS Purgatory: Mixed Irritable Bowel Syndrome – Symptoms can fluctuate rapidly, and psychological burden is onerous. Retrieved from http://www.medpagetoday.com/reading-room/aga/lower-gi/62101.

SOURCE

http://www.prnewswire.com/news-releases/additional-data-analysis-from-an-ibs-irritable-bowel-syndrome-clinical-trial-demonstrate-ibgard-delivered-unprecedented-symptom-reduction-in-the-largest-and-most-dissatisfied-group-of-ibs-patients-300454295.html

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