Digestive Health Research
While progress is being made in our understanding of the gastrointestinal disorders, important questions remain. For example:
- What causes the disorders?
- Why do certain people get them?
- How do we best treat the conditions?
- How do we prevent the disorders?
- How do we cure them?
Sound medical research is needed to explore these questions. Here we report a sampling of research studies and medical news that provide clues to better understanding GI disorders. Each new advance adds a small piece to the puzzle, making the big picture clearer.
To learn more about medical research, visit our web site at www.giResearch.org.
Topics - Newest Postings Listed First
- Linaclotide is now available in Europe
- FDA Advisory Committee on Relistor
- Functional Dyspepsia Medication Available in Japan
- Elobixibat now in Phase III Clinical Trials
- Three FGIMDs represented in new FDA Patient Perspective Initiative
- FDA Approves Lubiprostone to Treat Opioid-Induced Constipation
- PPI Approved For Use in Children with GERD
- FDA Approves Gattex to Treat Short Bowel Syndrome
- Linaclotide (Linzess) Now Available in U.S. Pharmacies
- FDA Approves Label Change for Amitiza
- Linaclotide Approved in Europe to Treat IBS-C
- Lubiprostone Available in Japan for Treatment of Chronic Constipation
- Participants Sought for IBS-D Study
- Lubiprostone Approved in U.K. to treat Chronic Constipation
- TSA Cares Help Line – Help for Those Traveling With Medical Conditions
- New Drug Application filed with FDA for Lubiprostone to treat Opioid-Induced Constipation
- The Human Microbiome in Health and Disease
- New Drug in Development for Treatment of IBS-D begins Phase 3 Study
- Positive Results Reported for Treatment of Anal Fissures
- Improving Patient Care through Innovation
- Understanding the Underlying Disease Process of Gastroparesis
- FDA Approves New Treatment for GERD
- FDA Issues Safety Alert Regarding PPI Risk Factor
- Lubiprostone Results Positive in Treating Opioid-Induced Bowel Dysfunction
- Opioids Increasingly Prescribed for Chronic Abdominal Pain in Adults despite Shortcomings
- Gastroparesis May Occur Less Often Than Thought in People with Diabetes
- FDA will Review the New Drug Application for Gattex to treat Short Bowel Syndrome
- Simple Breathing Exercises May Help GERD
June 13, 2013 – Linaclotide is now available in Europe (branded as Costella in the EU) to treat irritable bowel syndrome with constipation (IBS-C). Learn more
June 11, 2013 – Salix announced that the FDA will be holding an advisory committee to review Salix's Supplemental New Drug Application, which seeks to extend the use of this drug to include patients who are taking opioids to treat chronic pain.
Relistor was approved in the United States in 2008 for short term treatment of opioid-induced constipation, in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. It has also received approval for this indication in other countries.
June 6, 2013 – Astellas Pharma and Zeria Pharmaceutical have announced the launch of Acofide (acotiamide hydrochloride hydrate) for the treatment of functional dyspepsia in Japan. This will be the first approved treatment in a new drug class which has demonstrated effectiveness for functional dyspepsia. Read more about functional dyspepsia.
May 2, 2013 – Ferring Pharmaceuticals has begun phase III clinical trials of elobixibat. The studies are testing the efficacy and safety of repeated daily doses of elobixibat versus placebo for treating chronic idiopathic constipation. Learn more
(April 25, 2013) The U.S. Food and Drug Administration (FDA) has announced that irritable bowel syndrome (IBS), gastroparesis, and gastroesophageal reflux disease (GERD) with persistent regurgitation symptoms on proton pump inhibitors were selected as disease areas to be addressed during the first three years of its Patient-Focused Drug Development, a part of the Prescription Drug User Fee Act (PDUFA). Learn more.
(April 23, 2013) The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for lubiprostone (Amitiza) to treat opioid-induced constipation in adult patients with chronic non-cancer pain.
The drug was FDA approved in 2006 to treat chronic idiopathic constipation (CIC) in adults and in 2008 to treat irritable bowel syndrome with constipation (IBS-C) in adult women. Learn more
(March 23, 2013) The U.S. Food and Drug Administration (FDA) has approved the proton-pump inhibitor (PPI) ACIPHEX Sprinkle for treatment of GERD in children ages 1 to 11 years.
Approval of the treatment is based on the results of a multicenter, double-blind, parallel-group clinical trial in children. The study looked at 127 children with GERD confirmed by endoscopy. Overall, 81 percent of children achieved healing during the 12-week treatment period. The most commonly reported side effects during treatment were cough (14%), vomiting (14%), abdominal pain (12%), diarrhea (11%), fever (10%), headache (9%), upper respiratory tract infection (8%), sore throat (6%), and inflammation of the nasal passages and pharynx (5%).
(December 21, 2012) The FDA today approved teduglutide (Gattex) for the treatment of adults with short bowel syndrome (SBS). Learn more
(December 17, 2012) Linaclotide (Linzess) is now available in U.S. pharmacies for the treatment of chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults aged 17 and older. Learn more
(November 30, 2012) The FDA approved a Prescribing Label change for Amitiza that removed all pregnancy-related warnings and precautions. Nursing mothers who are taking Amitiza are advised to monitor their infants for diarrhea. Amitiza is a drug prescribed to treat chronic constipation in adults or IBS-C in women aged 18 and over.
(November 28, 2012) Almirall S.A. and Ironwood Pharmaceuticals report that the European Commission has granted marketing authorization for linaclotide (marketed under the brand name Constella) in Europe to treat IBS with constipation in adults. Constella is expected to be available in Europe in the first half of 2013.
The U.S. Food and Drug Administration (FDA) on August 30, 2012 approved linaclotide (Linzess) to treat irritable bowel syndrome with constipation (IBS-C) and to treat chronic idiopathic constipation in adults aged 17 and older. More...
(November 26, 2012) Lubiprostone (Amitiza), a prescription medicine for the treatment of functional chronic constipation, has been introduced in Japan by Sucampo Pharmaceuticals, Inc., a global pharmaceutical company, and Abbott. Amitiza was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in June.
(November 9, 2012) A study sponsored by Furiex Pharmaceuticals, Inc. is seeking people to participate in clinical trials of a new investigational medication for patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
Purpose of the study: To evaluate the effectiveness, safety, and tolerability of JNJ-27018966 (the Investigational drug) compared with an inactive placebo in patients with irritable bowel syndrome (IBS) with the subtype of diarrhea.
Participation: Eligible male and female patients aged 18 to 80 years with a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea.
For information call: 1-877-345-2145
(September 12, 2012) Sucampo Pharmaceuticals announced that it has received approval in the U.K. from the Medicines and Healthcare products Regulatory Agency for lubiprostone (Amitiza) 24 mcg twice daily for the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults, when response to diet and other non-pharmacological measures are inappropriate.
(August 1, 2012) The Transportation Security Administration (TSA) has a new helpline for travelers with disabilities and medical conditions.
Travelers may call TSA Cares toll free at 1-855-787-2227 prior to traveling, for help with questions about screening policies, procedures and what to expect at the security checkpoint with regards to their specific medical condition. If necessary, TSA Cares may be able to arrange checkpoint support with a TSA Customer Service Manager located at the airport.
TSA recommends that passengers call 72 hours ahead of travel. The TSA Cares helpline hours are Monday through Friday 8 a.m. – 11 p.m. EST and weekends and Holidays 9 a.m. – 8 p.m. EST.
(July 26, 2012) Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. announced the filing of a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for a new indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. Opioids are narcotics, such as morphine and codeine, used to treat pain. Lubiprostone currently is available under the name Amitiza to treat chronic idiopathic (functional) constipation and irritable bowel syndrome with constipation.
(June 25, 2012) The National Institutes of Health (NIH) reported that researchers have mapped the normal bacteria that live in and on the healthy human body. The accomplishment sets the stage for better understanding how bacterial communities affect human health and disease.
The human body is host to trillions of microbes. These microbes outnumber the body’s cells by 10 to 1. Most of the time they are beneficial to human health, but sometimes they can cause illness. Scientists are using new genomic techniques to study these microbial communities and their genes, which collectively are known as the microbiome.
The Human Microbiome Project (HMP) was launched by NIH in 2007 to characterize the microbes found in different regions of the body, including the digestive tract. The scientists studied the microbes of 242 healthy adult volunteers by collecting tissue from 15 body sites in men and 18 in women. The scientists found that more than 10,000 microbial species occupy the human body. They estimated that the microbiome provides more genes that contribute to human survival than the human genome itself provides (8 million vs. 22,000). Humans need bacterial genes to aid in basic processes such as digestion.
“Enabling disease-specific studies is the whole point of the Human Microbiome Project,” says Dr. Barbara Methé of the J. Craig Venter Institute. “Now that we understand what the normal human microbiome looks like, we should be able to understand how changes in the microbiome are associated with, or even cause, illnesses.”
Source: National Institutes of Health (NIH). NIH Research Matters web page: nih.gov/researchmatters/june2012/06252012microbiome.htm (Accessed June 25, 2012)
(June 15, 2012) Recruitment of male and female adult patients has started for the Phase 3 clinical study of MuDelta (JNJ-27018966), a novel drug under development for the treatment of irritable bowel syndrome with diarrhea as the predominant bowel symptom (IBS-D). Learn more here.
(June 1, 2012) Ventrus Biosciences reported positive data from a Phase 3 study treating patients suffering from anal fissures with its diltiazem hydrochloride cream (VEN 307). Ventrus reported the cream met the main goal of reducing pain.
An anal fissure is a tear in the anal lining that can cause severe anal pain, associated with or after bowel movements.
The double-blind, placebo-controlled study included 465 people across 31 centers in Europe. Ventrus plans to request a meeting with the US Food and Drug Administration (FDA) to discuss steps toward filing for approval.
(May 4, 2012) "The concept of the separation of mind and body is dominant and pervasive in Western thinking. This has had profound negative effects on research, patient care, and the patient-physician relationship," said Douglas Drossman, MD at a 12gurus: Health conference. These negative effects are often present with functional GI and motility disorders, complex conditions that many healthcare providers, as well as patients, find difficult to understand, manage, and treat.
Here is a video of the presentation by Dr. Drossman that talks about this concept and ways in which healthcare professionals can improve diagnosis and treatment of people with functional GI and motility disorders. View video here.
The 12gurus: Health conference held in March 2012 was attended by health care leaders and innovators to share ideas about changing and improving the health care system. Dr. Drossman was formerly the Co-director of the UNC Center for Functional GI and Motility Disorders. He is now in private practice at Drossman Gastroenterology, Chapel Hill, NC.
(April 18, 2012) Researchers have found evidence of changes at the cellular level in the stomachs of individuals with gastroparesis, yielding new insights into this digestive disorder.
Gastroparesis is a chronic condition characterized by impaired motility – the muscular contractions that move food along the gastrointestinal tract. This limited motility results in delayed food emptying from the stomach into the intestines, as well as many symptoms that compromise quality of life, including nausea, vomiting, bloating, weight loss, and abdominal pain. Gastroparesis is commonly associated with diabetes, which is thought to damage nerves connecting to the stomach that control muscular contractions. However, most often the cause of the disorder is unknown or “idiopathic.”
Clinical studies on this disorder have been limited. Scientists in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Gastroparesis Clinical Research Consortium are now conducting research at sites across the nation to improve understanding of disease processes and develop effective treatments for this disorder. For this study, they collected stomach tissue samples from individuals with diabetic and idiopathic forms of gastroparesis, as well as control samples from patients undergoing gastric bypass surgery who did not have gastroparesis, in order to compare their cellular structures. Scientists identified the types of cells in each sample and noted any cell damage.
Researchers noticed cellular abnormalities in the majority of samples from patients with either diabetic or idiopathic gastroparesis. The most frequent type of abnormality seen in stomach tissue from gastroparesis patients was a reduction in the number of interstitial cells of Cajal (ICCs), which play an important role as “pacemakers,” controlling muscular contractions in the stomach. Another common alteration was seen in the shape and increased number of immune cells present in the muscle layer. Some alterations in the gut nervous system were also observed. In addition to seeing certain cellular changes the researchers observed lack of visible contact between ICCs and neighboring nerve or muscle cells. Some unique cellular features were also noted between diabetic and idiopathic gastroparesis.
The finding of cellular abnormalities in the stomachs of most individuals with this disorder – including changes in the structure and number of ICCs, nerve cells, and immune cells – sheds light on the underlying disease processes at work in both forms of gastroparesis, and paves the way for future therapeutic development. Future research by the Consortium members will continue to explore these abnormalities, such as how loss of contact among these cells might translate into the limited gastrointestinal motility seen in patients with gastroparesis.
Adapted from: NIDDK Recent Advances & Emerging Opportunities.February 2012. Source: Grover M, Farrugia G, Lurken MS, et al. Cellular changes in diabetic and idiopathic gastroparesis. Gastroenterology. 140:1575-1585, 2011.
(March 27, 2012) Torax Medical announced that the U.S. Food and Drug Administration (FDA) approved the LINX Reflux Management System, a medical device for treating gastroesophageal reflux disease (GERD). The LINX System uses a small, implantable device to prevent the back-flow of stomach contents (reflux) in people with GERD who have not been helped by other treatments.
The LINX System is comprised of interlinked titanium beads with magnetic cores. The magnetic attraction between the beads augments the existing lower esophageal sphincter’s (LES) barrier function to prevent reflux. The device is implanted with a standard minimally invasive laparoscopic procedure.
Torax conducted a feasibility study of 44 patients at four centers with a five-year follow-up plan. In addition, the company conducted a pivotal study of 100 patients at 14 centers with a five-year follow-up plan. Patients enrolled had GERD and chronic GERD symptoms, despite medical therapy. Results from both the feasibility and pivotal trials indicate that the benefits obtained with the LINX Reflux Management System outweigh its risks.
The most common side effects experienced with the LINX included difficulty swallowing, pain when swallowing food, chest pain, vomiting, and nausea.
Torax said that they will work with medical centers that have a specific expertise in the treatment of reflux disease to create “Centers of Excellence” for the LINX System. Patients will have access to the LINX procedure within the next 30 days.
(February 8, 2012) The U.S. FDA today recommended that patients taking the stomach acid drugs known as proton pump inhibitors (PPIs) should immediately contact their healthcare professional and seek care if they develop diarrhea that does not improve. The FDA notice states that PPIs may be associated with an increased risk of Clostridium difficile–associated diarrhea. These PPIs include:
- AcipHex (rabeprazole sodium)
- Dexilant (dexlansoprazole)
- Nexium (esomeprazole magnesium)
- Omeprazole (omeprazole) Over-the-Counter (OTC)
- Prevacid (lansoprazole) and OTC Prevacid 24hr
- Prilosec (omeprazole) and OTC
- Protonix (pantoprazole sodium)
- Vimovo (esomeprazole magnesium and naproxen)
- Zegerid (omeprazole and Sodium bicarbonate) and OTC
Find more from the FDA at http://tinyurl.com/7ltpxm4
(February 2, 2012) Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A., Inc. announced that lubiprostone met the primary endpoint in a phase 3 clinical trial for the treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.
Opioids are narcotics, such as morphine and codeine, used to treat pain. A number of gastrointestinal (GI) symptoms are potential side effects of using opioid-based medications. The most common symptom is constipation. Others symptoms may include decreased gastric emptying, abdominal cramping, spasm, bloating, and delayed GI transit.
This phase 3, randomized, placebo-controlled, double-blinded trial looked at the efficacy and safety of lubiprostone in patients with opioid-induced bowel dysfunction. The primary endpoint was the overall spontaneous bowel movement (SBM) response rate. Over a 12 week period, the response rate for 219 lubiprostone-treated patients was 26.9% versus 18.6% for 220 placebo-treated patients.
The trial included patients in the U.S. and Europe who continued opioid therapy throughout the study.
No drug-related serious adverse events were reported for patients taking lubiprostone. The most common treatment-related adverse events (experienced by 5–10% of patients) were diarrhea, nausea, and abdominal pain.
Lubiprostone currently is available under the name Amitiza to treat chronic idiopathic (functional) constipation and irritable bowel syndrome with constipation. Submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for lubiprostone to treat opioid-induced bowel dysfunction is anticipated in the first half of 2012.
(February 2012) Opioids are narcotics used to treat pain. They are sometimes prescribed to treat chronic abdominal pain, such as pain in irritable bowel syndrome, as well as in other conditions. However, the use of opioids to treat non-cancer chronic pain is supported by evidence that is limited at best. Moreover, opioids are associated potentially with drug misuse and other gastrointestinal symptoms, particularly constipation. Over long time periods, even when used as directed, they may actually worsen abdominal pain.
A study published by Dorn and colleagues concluded that prescriptions for opioids to treat chronic abdominal pain in adults more than doubled during the period between 1997 and 2008. To conduct the survey, they looked at chronic abdominal pain-related visits by adults to U.S. outpatient clinics using reason-for-visit codes from the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey (1997–2008). Data were weighted to produce national estimates of opioid prescriptions over time.
The researchers speculate that several factors contributed to the increased prescribing including a tendency to generalize recommendations for the use of opioids in treating acute pain to include chronic pain, campaigns to recognize pain as the “fifth vital sign,” product advertising, and growing challenges clinicians face trying to manage chronic abdominal pain while unprepared to take the integrated approach that experts suggest.
Source: Dorn SD, Meek PD, Shah ND. Increasing frequency of opioid prescriptions for chronic abdominal pain in US outpatient clinics. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1078-85.e1.
(February 2012) When people with diabetes experience upper GI symptoms – such as nausea, vomiting, and stomach discomfort – gastroparesis is often considered. However, it may not be as common in this group as previously thought. A study by researchers at Mayo Clinic found that, while diabetes is a risk factor, only 5% of people with type 1 diabetes and 1% of people with type 2 diabetes developed gastroparesis over a 10-year period. Only 0.2% of people in the study without diabetes (controls) developed gastroparesis.
The researchers concluded that gastroparesis is a relatively uncommon complication of diabetes. Consequently, other causes of upper GI symptoms in people with diabetes need to be considered first. People suspected of having gastroparesis typically undergo tests, including examination of the esophagus and stomach. Testing to measure how fast the stomach empties is often used to confirm a diagnosis of gastroparesis. When testing shows normal emptying, functional dyspepsia is more likely the diagnosis.
The study gathered data on 1,226 people, including 587 with either type 1 or type 2 diabetes, and 639 without diabetes who served as controls.
Source: Choung RS, Locke GR, Schleck CD, Zinsmeister AR, Melton LJ, Talley NJ. Risk of gastroparesis in subjects with type 1 and 2 diabetes in the general population. Am J Gastroenterol. 2012 Jan;107(1):82-8. doi: 10.1038/ajg.2011.310. Epub 2011 Nov 15.
(January 31, 2012 – NPS Pharmaceuticals, Inc. announced that the FDA has accepted and filed for review the company's New Drug Application (NDA) for Gattex (teduglutide) for the treatment of adults with short bowel syndrome (SBS). Gattex works by regeneration of cells in the intestinal lining, slowing down transit through the gut and increasing blood flow, allowing for increased nutrient absorption. The acceptance of the Gattex NDA is the FDA’s determination that the application is sufficiently complete to permit a substantive review. More...
(January 2012) Looking for a way to help control gastroesophageal reflux (GERD) symptoms through lifestyle changes? A recent scientific study suggests that learning a simple breathing exercise may help.
Reflux is prevented by the lower esophageal sphincter (LES), which is surrounded by the diaphragm muscle. In a recent scientific study of 19 people who had active GERD without esophageal erosion, 10 were trained by a physical therapist to practice abdominal breathing exercises to strengthen the diaphragm muscle and 9 served as controls not doing breathing exercises. After one month, those doing the exercises reported an average improvement in quality of life, compared to the control group.
For long-term follow-up, after one month, all 19 were invited to continue active breathing training and were further assessed regarding quality of life and medication usage. Eleven people continued practice of abdominal breathing for nine months. They reported improved quality of life and using less on-demand reflux medication. The 8 people who quit the breathing exercises reported no changes in quality of life or medication use.
The study was very small and limited, so further research is needed before we know if this is a generally effective treatment for people with GERD symptoms. The study participants who did not stick with the breathing exercises through the whole nine-month follow-up period gave a variety of reasons – some preferred to take medication, some said they were “too lazy,” some reported that they did not have the time, and some that they thought the training was “useless.” So you’ll need to be dedicated about practicing these techniques if you hope to see results.
Source: Eherer AJ, Netolitzky F, Högenauer C, et al. Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. Am J Gastroenterol advance online publication 6 December 2011; doi: 10.1038/ajg.2011.420.
Want to try an abdominal breathing exercise for yourself? Follow the instructions below:
A Simple Breathing Technique
Typically, our breathing is either shallow and irregular (chest or thoracic breathing), or deep and regular (abdominal or diaphragmatic). Shallow chest breathing is often associated with tension. Deeper abdominal breathing, on the other hand, is associated with reduced tension and relaxation.
There are many breathing techniques that can be quickly and easily learned. While initially the positive effects are often subtle, benefits increase over time. Here is a simple breathing technique:
Notice your breathing gradually slowing, your body relaxing, and your mind calming as you practice this breathing technique.