Gastroenterology

Longitudinal Study on Inflammatory Bowel Disease to Explore Genetic and Immune Factors

A longitudinal study is being conducted to understand the natural history of inflammatory bowel disease (IBD) and the role of genetic and immune factors.

Study on Efferent Limb Stimulation Before Ileostomy Closure to Reduce Postoperative Ileus

A new protocol for stimulating the efferent limb of ileostomies prior to closure is being tested to improve microbiota recovery and reduce postoperative ileus.

Study Reviews Endoscopy Reports Post-Erlotinib in Familial Adenomatous Polyposis

The study aims to assess disease progression in familial adenomatous polyposis patients after stopping erlotinib treatment.

FDA Grants Approval for Polyethylene Glycol 3350 ANDA217505

The FDA has granted approval for ANDA217505, a generic formulation of Polyethylene Glycol 3350 by LNK INTL INC.

Barinthus Biotherapeutics Initiates First-in-Human Trial of VTP-1000 for Celiac Disease

Barinthus Biotherapeutics is conducting a first-in-human trial to evaluate the safety and tolerability of VTP-1000 in adults with celiac disease.

FDA Grants Approval for Prucalopride Succinate ANDA219234 by Alembic

The FDA has granted approval for Alembic's Abbreviated New Drug Application for Prucalopride Succinate.

FDA Submission Update for Omeprazole by Dr. Reddy's

Reddy's has submitted a supplemental application for Omeprazole (ANDA207740) with an unknown review priority.

Pfizer's PF-08049820 Study Examines Absorption Variability in Healthy Adults

Pfizer is conducting a study to evaluate the absorption and elimination of PF-08049820 in healthy adults, assessing food and drug interactions.

FDA Grants Approval for Pantoprazole Sodium ANDA219973

The FDA has granted approval for the ANDA219973 application for Pantoprazole Sodium submitted by Shuangcheng.

Study on Esophageal String Test for Eosinophilic Esophagitis in African Populations

A clinical trial is underway to evaluate the esophageal string test as a diagnostic tool for eosinophilic esophagitis among African individuals with dysphagia.

FDA Approval Process Update for Lactulose by Cumberland Pharmaceuticals

The FDA has an active application for Lactulose (ANDA074712) submitted by Cumberland Pharmaceuticals, currently under standard review.

Study on VR-Directed Therapy for Pain Management in IBD Patients

A study is underway to evaluate the feasibility and acceptability of VR-directed brain-gut behavioral therapy for hospitalized IBD patients.

FDA Grants Approval for Dicyclomine Hydrochloride ANDA216515

The FDA has granted approval for the ANDA216515 application for Dicyclomine Hydrochloride submitted by Rubicon Research.

Study Compares Topical Anesthesia to Propofol-Ketamine for GI Endoscopy

A clinical trial is underway to compare the efficacy and safety of a modified topical anesthesia technique against conventional intravenous sedation for upper gastrointestinal endoscopy.

Aurobindo Pharma's ANDA213511 for Eluxadoline Receives AP Status

Aurobindo Pharma's application ANDA213511 for Eluxadoline has received Abbreviated Approval (AP) status from the FDA.

Domperidone Updated with New Contraindication for Phaeochromocytoma Patients

Domperidone products now include a contraindication for patients with confirmed or suspected phaeochromocytoma due to severe hypertension risk.

Study on Endoscopic Submucosal Dissection for Early GI Neoplasia Launched in the UK

A multicentre cohort study is underway to evaluate endoscopic submucosal dissection for early gastrointestinal neoplasia.

Infliximab Trial for Acute Pancreatitis Shows Potential Efficacy

A randomized trial is evaluating infliximab's safety and effectiveness in treating acute pancreatitis.

Ethicon's RETHINK REFLUX Registry to Assess Long-Term Safety of LINX Device

The RETHINK REFLUX Registry will evaluate the long-term safety of the LINX device over a 10-year period.

Phase I Study on Transdermal Delivery of Neostigmine for Bowel Care in SCI Patients

A Phase I pilot study is investigating the transdermal delivery of neostigmine and glycopyrrolate for bowel evacuation in individuals with spinal cord injury using iontophoresis.

FDA Accepts Supplemental NDA for Linzess by AbbVie

The FDA has accepted a supplemental NDA for Linzess (linaclotide) submitted by AbbVie, indicating a priority review.

FDA Accepts ANDA for Esomeprazole Magnesium by Marksans Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium submitted by Marksans Pharma.

FDA Acceptance of Linaclotide ANDA Submission by Actavis Labs

The FDA has accepted the ANDA submission for Linaclotide by Actavis Labs.

IL-37 Shows Protective Role in Inflammatory Bowel Disease and Colitis-Associated Cancer

IL-37 is upregulated in inflammatory bowel disease and colitis-associated cancer, exerting protective anti-inflammatory effects.

Enhanced intestinal delivery of volatile phytotherapeutics via self-microemulsifying systems

Developed solid self-microemulsifying drug delivery systems (SMEDDS) for improved intestinal absorption of phytotherapeutics.

Lupin's Famotidine ANDA217432 Receives Abbreviated Approval from FDA

Lupin has received an Abbreviated Approval (AP) for its ANDA217432 application for Famotidine.

Real-World Study of IL-23 Inhibitors in Active Crohn's Disease Launched

A real-world observational study has been initiated to assess the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease.

FDA Approval Update for Omeprazole ANDA207740 by Dr. Reddy's

Reddy's has submitted an Abbreviated New Drug Application (ANDA) for Omeprazole, currently under review.

Study on Partial Enteral Nutrition Augmenting Therapy in Active Crohn's Disease

A multicenter trial is investigating the efficacy of partial enteral nutrition combined with pharmacologic therapy in Crohn's disease.

Comparative Study of AI vs Narrow Band Imaging for IBD Cancer Surveillance

A study is comparing AI-assisted detection with narrow-band imaging for identifying dysplasia in IBD patients during colonoscopy.

Anagram Therapeutics initiates Phase 2 trial for ANG003 in exocrine pancreatic insufficiency

Anagram Therapeutics is conducting Phase 2 study to evaluate the safety and efficacy of ANG003 for exocrine pancreatic insufficiency.

Trial on Text-Based Monitoring for IBD Outcomes and Patient Empowerment

A clinical trial is assessing the impact of text messaging on disease management and outcomes in IBD patients.

FDA Grants Approval for Prucalopride Succinate by Micro Labs

The FDA has granted approval for Prucalopride Succinate under application ANDA219180 submitted by Micro Labs.

FDA Accepts Supplement Application for Omeprazole Magnesium by Marksans Pharma

The FDA has accepted a supplement application (ANDA218829) for Omeprazole Magnesium submitted by Marksans Pharma.

Mayo Clinic Study on Secretin's Effect on Pancreatic Fluid Composition

A study is underway to evaluate the effect of secretin on pancreatic fluid composition in healthy subjects.

Janssen's Guselkumab Compared to Risankizumab in Crohn's Disease Study Initiated

A clinical trial has been initiated to compare the efficacy of guselkumab and risankizumab in treating moderately to severely active Crohn's Disease.

Phase III Trial of Afimkibart Shows Promise for Moderately to Severely Active Crohn's Disease

A Phase III trial is underway to assess the efficacy and safety of Afimkibart in Crohn's disease patients.

FDA Grants Approval for Pantoprazole Sodium ANDA219973

The FDA has granted approval for ANDA219973, a generic version of Pantoprazole Sodium, submitted by Shuangcheng.

Phase II Trial Comparing IOUS-Guided Margin Selection in Crohn's Disease Surgery

A Phase II trial is underway to compare intraoperative ultrasound (IOUS)-guided margin selection with standard methods in ileocolic resection for terminal ileal Crohn's disease.

FDA Grants AP Status for Lactulose ANDA074712 by Cumberland Pharmaceuticals

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Lactulose submitted by Cumberland Pharmaceuticals.

Milpharm Limited Issues Class 4 Medicines Defect Notification for Loperamide Hydrochloride

A discrepancy has been identified in the Patient Information Leaflet for Loperamide hydrochloride 2 mg Orodispersible Tablets.

Phase 1 Trial of MTP-101P for Safety in Colon Resection Patients

A Phase 1 pilot trial is underway to assess the safety and feasibility of MTP-101P in patients undergoing colon resection.

Phase III Trial of Afimkibart Shows Promise for Ulcerative Colitis

A Phase III trial is underway to assess the efficacy and safety of Afimkibart in patients with moderately to severely active ulcerative colitis.

Genentech's Vixarelimab Shows Promise in Moderate to Severe Ulcerative Colitis

A study is underway to evaluate the pharmacodynamic effects of vixarelimab in patients with moderate to severe active ulcerative colitis.

Study on External Pancreatic Stent to Prevent Fistula Post-Pancreatoduodenectomy

A clinical trial is investigating the effectiveness of external pancreatic stents in preventing pancreatic fistula after pancreatoduodenectomy.

Vitamin D Supplementation May Improve Iron Status in IBD Patients

A pilot study is evaluating the impact of vitamin D supplementation on iron parameters in adults with inflammatory bowel disease.

Comparative Study of EMR and ESD for Barrett's Neoplasia Initiated

A randomized clinical trial is underway to compare the efficacy of endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) in patients with Barrett's esophagus and visible dysplastic lesions.

Trial Comparing Botox Alone vs Combined Treatment for Chronic Anal Fissure

A prospective trial will compare the effectiveness of injection Botox alone versus Botox combined with fissurectomy and anoplasty in chronic anal fissure patients.

Study on Ustekinumab for IBD Patients Switching from Anti-TNFα Due to Psoriasis

A study is investigating the outcomes of children with Crohn's disease or ulcerative colitis who switch from anti-TNFα therapy to ustekinumab due to paradoxical psoriasis.

Study on Zonulin and LBP as Biomarkers in UC and Liver Disease

The study aims to explore the relationship between zonulin, LBP biomarkers, and liver conditions in UC patients.

Study on Electroacupuncture's Impact on Bowel Motility in Healthy Subjects

A clinical trial is investigating the effects of electroacupuncture at NP82 and SP15 on bowel motility in healthy subjects.

AbbVie initiates pediatric study of Risankizumab for Ulcerative Colitis

A new study is underway to evaluate the safety and efficacy of Risankizumab in pediatric patients with moderate to severe Ulcerative Colitis.

RESTOREGI Study Evaluates Regenerative Therapy for Benign GI Fistulas

The RESTOREGI study aims to identify factors influencing healing in benign gastrointestinal fistulas treated with tSVF-EM therapy.

FDA Grants AP Status for Pantoprazole Sodium Supplement by Meitheal

The FDA has granted Abbreviated Approval (AP) status for the Pantoprazole Sodium supplement submitted by Meitheal.

Study on Dual-Target Combination Therapies for Inflammatory Bowel Disease Initiated

A study is underway to evaluate the effectiveness and safety of dual-target combination therapies in IBD patients.

Merck's Tulisokibart Achieves Key Endpoints in Phase 3 UC Study

Tulisokibart met its primary endpoint of clinical remission at 12 weeks in Phase 3 trial for ulcerative colitis.

FDA Grants Approval for Rabeprazole Sodium ANDA204237

The FDA has granted approval for ANDA204237, a supplemental application for Rabeprazole Sodium submitted by Rubicon Research.

AI System for Enhanced Detection of Colonic Sessile Serrated Lesions in Colonoscopy

A study is evaluating the effectiveness of a real-time Computer Aided Detection system for identifying sessile serrated lesions during colonoscopy.

Eli Lilly's LY4268989 Study with Mirikizumab in Ulcerative Colitis Underway

A clinical trial is evaluating the safety and effectiveness of LY4268989 co-administered with mirikizumab in adults with moderately to severely active ulcerative colitis.

Pilot Study on Non-Invasive Vagus Nerve Stimulation in IBD Remission

The VIBRANT-IBD study is assessing the feasibility of non-invasive vagus nerve stimulation in IBD patients in remission.

Trial Evaluates Dispepril® Efficacy in Functional Dyspepsia vs. Proton Pump Inhibitors

A clinical trial is underway to assess the efficacy of Dispepril®, a nutraceutical, in treating functional dyspepsia compared to standard PPI therapy.

Boomerang Medical initiates pivotal trial for device in ulcerative colitis

Boomerang Medical is conducting a pivotal trial to evaluate a device aimed at reducing bowel urgency in ulcerative colitis patients.

Phase III Trial of Hemay005 in Chinese Patients with Ulcerative Colitis Initiated

A phase III trial has been initiated to evaluate Hemay005 for the treatment of moderately to severely active ulcerative colitis in Chinese patients.

Pfizer's Phase 3 Study of Tofacitinib in Pediatric Ulcerative Colitis Underway

Phase 3 Study of Duvakitug for Moderately to Severely Active Ulcerative Colitis Initiated

A Phase 3 maintenance study is underway to evaluate duvakitug's efficacy and safety in patients with moderately to severely active Ulcerative Colitis.