ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
Functional Gastrointestinal DisordersIrritable Bowel Syndrome2 moreThis open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered CBT-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.
Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation
Functional ConstipationGastrointestinal Disease1 moreThe safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Our study aimed to explore the clinical application of a newly developed smartphone-controlled multi-mode VC in the treatment of functional constipation (FC) on multicentres. Patients referred to gastroenterology outpatient of Changhai Hospital with FC and met the eligible criteria for more than 6 months and with spontaneous complete bowel movement (SCBM) less than 3 times per week within recent 3 weeks were eligible for this study. The study was discussed with patients who satisfied the enrolment criteria and provided written informed consents.
Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders...
Irritable Bowel SyndromeDyspepsia ChronicAbdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and no safe and effective treatment is available. Although probiotics have shown promising results in adults, few studies have been published in children. The Bifidobacterium Infantis, Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria in children and represent 95% of the total bacterial population in the intestine of breastfed infant. Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life in children with FD and IBS.
Eradication Rate Between 1- and 2-Week Helicobacter Pylori Eradication Therapy
H.Pylori Gastrointestinal DiseaseIt is recommended as the first line treatment regimen to eradicate Helicobacter pylori (HP), 7 or 14 days treatment of proton pump inhibitor (PPI) based triple therapy consisting of one PPI and two antibiotics, clarithromycin and amoxicillin. In the case of treatment failure, 7 or 14 days of quadruple therapy (PPI+metronidazole+tetracycline+bismuth) is recommended. This study aims to investigate which duration would be better for eradication of HP. The study design is a randomized controlled trial. The patients were randomly assigned to 7 days or 14 days treatment groups. Primary endpoint was the eradication rate of PPI based triple therapy. Secondary endpoints were to compare the rate of drug compliance and side effects in both groups.
Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
Functional Gastrointestinal DisordersSubjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods. Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms and gas retention for 3 h) will be performed before and at the end of the intervention phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal bifidobacteria counts will be measured before and at the end of the intervention.
Localized Therapeutics for the Treatment of Gastrointestinal Disorders II
ColitisUlcerativeThe purpose of this study is to investigate a novel thermosensitive topical gel formulation for the treatment of inflammatory bowel disease (IBD), specifically ulcerative colitis.
PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
Hepatic ImpairmentLiver Diseases1 moreThis is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with mild, moderate, and severe hepatic impairment (defined as Child-Pugh A, B, and C, respectively) and matched healthy volunteers with normal hepatic function.
Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders:...
Irritable Bowel SyndromeFunctional Gastrointestinal DisordersThis pilot-study aims to evaluate the treatment effects and feasibility of an internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic...
Pancreatic InsufficiencyCystic Fibrosis3 moreThe purpose of this Randomized, Double-blind, Multicenter, Two-period Crossover Study is to Assess the Efficacy and Tolerability of Burlulipase (NM-BL) in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
The EVICEL® Gastrointestinal Study
Gastrointestinal DiseasesThe purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.