Hypnotherapy Through Self-exercises in Children With Functional Abdominal Pain in Primary Care
Functional Gastrointestinal DisordersIrritable Bowel Syndrome1 moreThe goal of this randomised controlled trial is to study the (cost-)effectiveness of home-based hypnotherapy by self-exercises in children with functional abdominal pain (FAP) or irritable bowel syndrome (IBS) in primary care. The main questions it aims to answer are: What is the effect of home-based hypnotherapy by self-exercises on adequate relief of abdominal pain and discomfort in addition to care as usual of general practitioners (GPs), compared to care as usual of GPs alone in children with FAP or IBS? What is the effect of home-based hypnotherapy by self-exercises in addition to care as usual by GPs compared to care as usual of GPs alone in children with FAP or IBS on: Frequency and intensity of abdominal pain and discomfort Pain severity Daily functioning and impact Anxiety and depression Pain beliefs Sleep disturbances School absence Use of health care services, including GP visits and referrals to secondary care Costs (healthcare and societal perspective) Participants in the intervention group will receive home-based hypnotherapy 5 times a week for approximately 15-20 minutes a day during 3 months in addition to care as usual by their GP according to the Dutch society of GPs' guideline for children with abdominal pain. Participants in the control group will receive care as usual by their GP according to the Dutch society of GPs' guideline for children with abdominal pain.
Low FODMAP Diet in FD (PDS)
Functional Gastrointestinal DisordersThe goal of this dietary intervention study is to assess the efficacy and mechanisms of a low-FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet in functional dyspepsia patients. The main questions it aims to answer are: If a low-FODMAP diet can reduce dyspeptic complaints How a low-FODMAP diet can reduce dyspeptic complaints in functional dyspepsia (FD). Participants will follow a 6-week during low-FODMAP diet followed by powder reintroduction of 6 FODMAPs and 1 control substance.
A First-in-human (FIH) Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal...
Gastrointestinal Stromal Tumor (GIST)Digestive System Disease2 moreThis is the first clinical trial of IDRX-42. The study is designed to evaluate the safety, tolerability, PK, and preliminary antitumor activity of IDRX-42 in adult participants with advanced (metastatic and/or surgically unresectable) GIST.
Growth Hormone in Decompensated Liver Cirrhosis
Liver CirrhosisFibrosis5 moreGlobally, cirrhosis and liver cancer carries a huge burden and accounts for about 3.5% (2 million) of all deaths every year. Once decompensated, i.e. development of ascites, variceal bleed, encephalopathy, and jaundice, the life expectancy is markedly reduced to a median of two years. The definitive treatment in this stage, i.e., liver transplantation is limited by cost, lack of donors, and life-long immunosuppression. In addition to complications due to portal hypertension and hepatic insufficiency, decompensated cirrhosis is associated with malnutrition, sarcopenia, immune dysfunction, and impaired regeneration. Patients with cirrhosis are growth hormone (GH) resistant, with reduced insulin-like growth factor, which are linked to malnutrition and poor liver regeneration in cirrhosis. Diverse preclinical and clinical investigations in vitro and in vivo, have shown a benefit of GH in GH deficient, elderly and HIV positive patients. GH therapy in cirrhosis has been shown to improve nitrogen economy and to improve the GH resistance in a small pilot study by Donaghy et al. Also, GH therapy of short duration has shown to increase IGF1 levels, IGFBP-3 levels in patients of cirrhosis. GH therapy has also been shown to improve liver regeneration and protein synthesis after hepatectomy in patients of HCC with cirrhosis. However, there is a scarcity of data on clinical impact of long term administration of GH therapy in patients of cirrhosis. Hence, we undertook the present study to study the effect of growth hormone on clinical outcomes, malnutrition, immune cells and liver regeneration in patients with cirrhosis.
Effect of Fecal Microbiota Transplantation (FMT) in Pediatric Functional Gastrointestinal Disorders...
Functional Gastrointestinal DisordersSafety and efficacy of FMT in Pediatric Functional
Jing Si Herbal Tea for Long-Coronavirus Disease(COVID) Gut-brain Interaction
Healthy SubjectsCOVID-19 Pneumonia2 moreDyspepsia refers to chronic or recurrent upper gastrointestinal symptoms. According to the Rome IV criteria, functional dyspepsia (FD) symptoms included meal related fullness, early satiation, epigastric pain or burning which are unexpl ained after routine investigation. FD causes substantial psychophysical burden because of its unknown etiology and high prevalence. Although FD is currently associated with local inflammation of the gastrointestinal tract and microbiota alteration, current available treatments for FD are of limited effectiveness. In view of this, many studies have applied Chinese herbal medicine in FD and achieved some therapeutic benefit. The Jing Si Herbal Tea Liquid Packet composed of eight native Taiwanese herbs (wormwo od, hickory grass, Ophiopogon japonicus, houttuynia cordata, platycodon,licorice, perilla leaves, chrysanthemum) has obtained a special export license from the Ministry of Health and Welfare. The Jing Si Herbal Tea Liquid Packet also has been registered i n clinical trials as a complementary treatment for Coronavirus disease 2019(COVID-19). The preliminary data demonstrated that the Jing Si Herbal Tea Liquid Packet may improve gastrointestinal symptoms and anxiety in patients with COVID-19. Therefore,this study aims to investigate the impact of the Jing Si Herbal Tea Liquid Packet on psychophysical burden and metabolites of microbiota in patients with FD through a double blind randomized manner.
Stigma and Efficacy of Zhizhu Kuanzhong Capsules
Functional Gastrointestinal DisordersDyspepsia1 moreAntidepressants are effective in patients with functional dyspepsia (FD), however, the stigma related with FD and antidepressants could affect treatment adherence and efficacy. Zhi Zhu Kuan Zhong capsules (ZZKZ), a traditional Chinese medicine fomula, showed therapeutic potential for FD. The study was designed to investigate whether ZZKZ could alleviate stigma in FD and obtain identical effects in patients with refractory FD.
Domperidone in Treating Patients With Gastrointestinal Disorders
Digestive System DisorderDyspepsia5 moreThis phase III trial studies how well domperidone works in treating patients with gastrointestinal disorders. Domperidone may help control chronic gastrointestinal disorders and their symptoms, such as pain, bloating, and nausea and vomiting, by stimulating contraction of the stomach to increase its ability to empty itself of food.
The Role of Neuromodulators in Refractory Functional Dyspepsia
DyspepsiaFunctional Gastrointestinal Disorders2 moreThe study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia
SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids
HemorrhoidsHemorrhoids5 moreThe SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 5 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months will be monitored to evaluate the result after a PexyEazy® procedure.