Gail S. Thornton
West Mill Consulting
12-MONTH POST-MARKETING SAFETY SURVEILLANCE DATA PRESENTED AT THE AMERICAN COLLEGE OF GASTROENTEROLOGY (ACG) ANNUAL MEETING CONFIRMS THE EXCELLENT SAFETY AND TOLERABILITY PROFILE OF Fiber Choice® (CHEWABLE INULIN FIBER), A WELL-STUDIED, CHEWABLE PREBIOTIC FIBER SUPPLEMENT
- Real-world, safety surveillance study, CIFSU12 (Chewable Inulin Fiber Safety Update at 12 months™) confirms the favorable safety and tolerability profile for Fiber Choice®
- No serious adverse events for Fiber Choice were reported
- Contrary to conventional thinking, the rates on non-serious adverse events, such as flatulence or abdominal discomfort, were remarkably low
- Fiber Choice contains a well-studied prebiotic fiber, inulin, that helps support regularity and the growth of beneficial microorganisms for general digestive health
- Inulin is a natural fiber found in 30,000 fruits and vegetables1,2
- The convenience, taste, and efficacy of Fiber Choice help make it the #1 gastroenterologist recommended* to help address the “fiber gap” in American diets
San Antonio, Texas – (October 29, 2019) – IM HealthScience® (IMH®), innovators of medical foods and dietary supplements, today announced favorable results from a real-world, 12-month, post-marketing safety surveillance study for Fiber Choice® prebiotic fiber supplements (chewable inulin fiber tablets and gummies). This study, called CIFSU12 (Chewable Inulin Fiber Safety Update at 12 months™), examined the safety and tolerability of Fiber Choice during a 12-month period.
The results were presented by Michael S. Epstein, M.D., FACG, AGAF, one of the study authors, during ACG 2019, the American College of Gastroenterology’s Annual Scientific Meeting and Postgraduate Course. Dr. Epstein is a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. ACG is the preeminent professional organization that works on delivering evidence-based health care to gastroenterology patients through scientific investigation, education, prevention, and treatment.
Inulin, the well-studied, 100 percent natural, prebiotic, soluble fiber in Fiber Choice, is found in 30,000 fruits and vegetables.1,2 In clinical trials, inulin has been shown to help support digestive health, including helping support regularity.3 Additionally, inulin supports the growth of the body’s own beneficial bacteria, including Lactobacillus and Bifidobacterium, in the colon.4
About CIFSU12 Study
An analysis of the 12-month, post-marketing safety surveillance data for Fiber Choice®, called CIFSU12 (Chewable Inulin Fiber Safety Update at 12 months™), showed that:
- An estimated 809,300 individual patients consumed Chewable Inulin Fiber (Fiber Choice) during the surveillance period.
- No serious adverse events were reported.
- The self-reporting rate of non-serious adverse events was low, with only 23 non-serious events reported by 21 individuals for a total rate of 2.8 per 100,000 users.
- The top reported non-serious events were flatulence (4), diarrhea (3) and abdominal discomfort (2). However, the rates for these were extremely low, with 4.9, 3.7, and 2.4 per million, respectively.
“Dietary fiber is known for helping keep our bodies regular,” said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor of IM HealthScience. “Most importantly, it’s essential that people get enough fiber in their diets. One way to do that is to supplement the daily intake of dietary fiber with prebiotic fiber supplements. The important marketplace use data in CIFSU12 reconfirms that Fiber Choice can be an excellent option for fiber supplementation.”
Less than 3 percent of Americans get the recommended minimum amount of fiber, and 97 percent need to increase their fiber intake5. Although the recommended daily fiber intake is 25 to 38 grams6, most Americans only get about half that amount. This “fiber gap” reflects a diet with relatively few high-fiber foods, such as fruits, vegetables, nuts, legumes, and whole grains, and is a large enough issue for the U.S. government to deem it a “public health concern” for most of the U.S. population.
CIFSU12 captured and analyzed serious and non-serious adverse event reports for Fiber Choice over a 12-month period from January 1, 2018 to December 31, 2018 in accordance with MedDRA standards. A call-in number for reporting adverse events was provided on bottles of Fiber Choice.
An independent call center staffed with pharmacovigilance-trained health care personnel in accordance with U.S. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events, was retained to receive and record customer adverse events.
Increasing Evidence of the Safety and Efficacy of Fiber Choice®
Results of an important patient-reported outcomes study, entitled CIFPRO (Chewable Inulin Fiber Patient Reported Outcomes™), were peer reviewed and presented at the American College of Gastroenterology Annual Meeting in 2018.7 CIFPRO, a real-world study of patients who took Fiber Choice®, provided confirmatory evidence – in combination with results from a previous randomized clinical trial3 – demonstrating improved bowel regularity, rapid symptom improvement, and patient satisfaction with Fiber Choice fiber supplement.
The CIFPRO study included 185 self-reported responses to a nine-question online survey from November 2017 to July 2018 from individuals who received a physician-dispensed sample of the supplement.
Data from the patient-reported CIFPRO study showed that:
- 9% of respondents said they were extremely satisfied or satisfied with Fiber Choice.
- More than two-thirds (70.8%) of respondents rated their bowel regularity as very much improved or improved while taking Fiber Choice.
- 6% of respondents indicated they would be likely or very likely to recommend Fiber Choice to others, and its taste was rated as good to excellent by 93.5% of respondents.
- Before taking Fiber Choice, most respondents (80.6%) suffered from irregularity every day or a few days per week.
About Fiber Choice®
The Fiber Choice® brand of chewable fiber tablets and gummies is made from inulin [pronounced: in-yoo-lin], a natural fiber found in many fruits and vegetables. The inulin in Fiber Choice is sourced from a vegetable (chicory root). Inulin works by helping to build healthy, good bacteria in the colon. It keeps food moving through the system, supporting the digestive tract and helping to support regularity.
Research shows that the digestive system does more than digest food: it plays a central role in the immune system. The healthy bacteria that live in the digestive tract promote immune system function, so prebiotic fiber helps nourish the body.
In a recent national survey, the Fiber Choice line of chewable prebiotic fiber tablets and gummies achieved the #1 share of gastroenterologist (GE)8 recommendations.*
The usual adult dosage with Fiber Choice Chewable Tablets is two tablets, up to three times a day, and for Fiber Choice Fiber Gummies, it is two gummies, up to three times a day.
Fiber Choice is available in the digestive aisle at major retailers nationwide, including Walmart, CVS/pharmacy, Target, Rite Aid, and many other drug and food retailers. It can also be purchased online at Amazon.
About the American College of Gastroenterology
Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 14,000 individuals from 85 countries. The ACG seeks to be the preeminent champion for prevention, diagnosis, and treatment of digestive disorders by facilitating the highest quality, compassionate, and evidence-based patient care. www.gi.org. ACG can be followed on Twitter @AmCollegeGastro.
About IM HealthScience®
IM HealthScience® (IMH®) is the innovator of the medical foods IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD or recurring, often meal-triggered indigestion), respectively. IBS may often migrate to FD, and vice versa, or both conditions may overlap in the same patient.9 IMH rounds out its line of digestive products with Fiber Choice®, a well-known, natural chewable prebiotic fiber supplement that helps with regularity. IMH, along with its sister company, Physician’s Seal® (PS), also co-markets the innovative sleep product, REMfresh®. REMfresh is the first and only continuous release and absorption melatonin (CRA-melatonin™) supplement for sleep. It is a 99 percent ultrapure melatonin that mimics the way the body naturally releases and maintains melatonin over a 7-hour period.
IMH is a privately held company based in Boca Raton, Florida. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. Both IMH and PS are dedicated to developing products to address overall health and wellness in digestive health and sleep. The IM HealthScience and Physician’s Seal advantage comes from developing products based on patented, targeted-delivery technologies, including IPP® (Ion-Powered Pump®) and SST® (Site-Specific Targeting®) technologies. For more information, visit www.imhealthscience.com to learn about the company, or www.IBgard.com, www.FDgard.com, www.FiberChoice.com, and www.REMfresh.com.
Visit IM HealthScience at booth #1438 to learn more about Fiber Choice®.
Data Presented at ACG 2019 Poster Session on October 29, 2019, 1 PM to 2:15 pm
- (Poster #1934) 24-Month Post Marketing Safety Surveillance Data of Chewable Inulin Fiber (CIF)
- Brian Lacy, PhD, MD, FACG, Michael Epstein, MD, FACG, Patrick Corsino, PhD.
* IQVIA, ProVoice Survey June 2019: Among gastroenterologists recommending chewable fiber tablets and gummies.
- Apolinário AC, De Lima Damasceno BPG, De Macêdo Beltrão NE, Pessoa A, Converti A, Da Silva JA. Inulin-type fructans: A review on different aspects of biochemical and pharmaceutical technology. Carbohydr Polym. 2014;101(1):368-378. doi:10.1016/j.carbpol.2013.09.081
- Ghavami A, Roshanravan N, Alipour S, et al. Assessing the effect of high performance inulin supplementation via KLF5 mRNA expression in adults with type 2 diabetes: A randomized placebo controlled clinical trial. Adv Pharm Bull. 2018;8(1):39-47. doi:10.15171/apb.2018.005
- Micka A, Siepelmeyer A, Holz A, Theis S, Schön C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017;68(1):82-89. doi:10.1080/09637486.2016.1212819
- Shoaib M, Shehzad A, Omar M, et al. Inulin: Properties, health benefits and food applications. Carbohydr Polym. 2016;147:444-454. doi:10.1016/j.carbpol.2016.04.020
- Moshfegh A, Goldman J, Cleveland L. What We Eat in America, NHANES 2001-2002: Usual Nutrient Intakes from Food Compared to Dietary Reference Intakes – U.S. Department of Agriculture, Agricultural Research Service.; 2005.
- Institute of Medicine; Food and Nutrition Board. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids.; 2005. doi:https://doi.org/10.17226/10490
- Lacy B, Epstein M, Shah S, Corsino P. Improved regularity with a chewable inulin fiber (CIF): results from a Patient Reported Outcomes (PRO) study. In: American College of Gastroenterology Annual Conference – Philadelphia, PA. ; 2018.
- IQVIA, ProVoice Survey June 2019: Among Gastroenterologists Recommending Chewable Fiber Tablets and Gummies.
- Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014;6(1):71-80. doi:10.2147/CLEP.S40245
This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. This information should not be used for diagnosing a health problem or disease. While medical foods do not require prior approval by the FDA for marketing, they must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. Only doctors can definitively diagnose functional dyspepsia. Use under medical supervision. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fiberchoice.com. Individual results may vary.