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Diarrhea Secondary to Medications

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161. Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism)

Etelcalcetide (Parsabiv) - reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism) 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2016. Reproduction is authorised provided the source (...) of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.1.1. Problem statement 8 2.1.2. About the product 9 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 10 General information 10 Manufacture, characterisation and process controls 10 Specification 11 Stability 12 2.2.3. Finished Medicinal Product 12 Manufacture of the product and process controls 13 Product specification 13 Stability of the product 14 Adventitious agents 15 2.2.4. Discussion on chemical, pharmaceutical

2016 European Medicines Agency - EPARs

162. Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Children Aged 3 to 60 Months Suffering From Acute Diarrhea

Study Completion Date : September 1, 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Racecadotril plus standard treatment oral rehydration solution Drug: Racecadotril plus ORS Racecadotril plus ORS Outcome Measures Go to Primary Outcome Measures : Duration of diarrhea (hours) between the start of treatment until last diarrheal/watery stool before recovery or end of study treatment (treatment (...) duration maximal 5 days [ Time Frame: 5 days ] Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary Secondary Outcome Measures : Number of recovered subjects [ Time Frame: 5 days ] Number of recovered subjects Global Physician Assessment at the end of treatment [ Time Frame: 5 days ] scores 1-6 Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal

2018 Clinical Trials

163. Controlled Study to Evaluate the Efficacy and Safety of Racecadotril in Infants, Children and Adolescents With Acute Diarrhea

, 2018 Actual Study Completion Date : September 10, 2018 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Racecadotril plus standard treatment oral rehydration solution Drug: Racecadotril plus ORS Racecadotril plus ORS Active Comparator: ORS (standard treatment) Drug: ORS ORS Outcome Measures Go to Primary Outcome Measures : Duration of diarrhea (hours) between the start of treatment until last diarrheal (...) /watery stool before recovery or end of study treatment (treatment duration maximal 5 days) [ Time Frame: 5 days ] Duration of diarrhea is defined by date and time of the evacuation of the final diarrheal stool derived from the daily diary Secondary Outcome Measures : Number of recovered subjects per treatment group [ Time Frame: 5 days ] Number of recovered subjects per treatment group Global Physician Assessment at the end of treatment [ Time Frame: 5 days ] scores 1-6 Eligibility Criteria Go

2018 Clinical Trials

164. Effects of Eluxadoline (Viberzi®) 100 mg Twice Daily on Diarrhea-Associated Fecal Incontinence

: Not yet recruiting First Posted : April 5, 2018 Last Update Posted : February 27, 2019 See Sponsor: University of North Carolina, Chapel Hill Collaborator: Allergan Information provided by (Responsible Party): University of North Carolina, Chapel Hill Study Details Study Description Go to Brief Summary: Accidental bowel leakage (fecal incontinence) increases in people who have diarrhea and sensations of urgency to have a bowel movement. Drugs such as loperamide (Imodium) that reduce diarrhea improve (...) accidental bowel leakage, but loperamide has disadvantages: it is difficult to find a dose that does not cause constipation, and it does not reduce urge sensations. Eluxadoline is a new drug that is effective for reducing diarrhea, abdominal pain, and urgency in patients with irritable bowel syndrome, and it may be less likely than loperamide to cause severe constipation. Therefore, eluxadoline may help patients manage accidental bowel leakage caused by diarrhea. The chemical name for Viberzi®

2018 Clinical Trials

165. Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea

. University of Michigan More Information Go to Layout table for additonal information Responsible Party: William Chey, Professor of Internal Medicine, Medical School and Professor of Nutritional Sciences, School of Public Health, University of Michigan ClinicalTrials.gov Identifier: Other Study ID Numbers: HUM00142925 First Posted: November 2, 2018 Last Update Posted: February 8, 2019 Last Verified: February 2019 Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes (...) ) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study. Condition or disease Intervention/treatment Phase Irritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea Drug: Rifaximin Device: Glucose and lactulose hydrogen breath testing Phase 4 Detailed Description: The study aims to determine whether hydrogen breath testing can be used to identify patients

2018 Clinical Trials

166. Antibacterial activity and in situ efficacy of Bidens pilosa Linn and Dichrostachys cinerea Wight et Arn extracts against common diarrhoea-causing waterborne bacteria. Full Text available with Trip Pro

sensitive to the effect of different extracts of both plant species, with E. coli being less sensitive to the effect of the extracts from D. cinerea. Following the simulated gastric fluid (SGF) treatment, a decrease in the antibacterial potency of the extracts was observed. No extract was toxic to the C2C12 muscle cell line.The presence of the secondary metabolites and nontoxic effect of the two plants tested may affirm the medicinal value of these leaf extracts. Our results suggest that B. pilosa and D (...) Antibacterial activity and in situ efficacy of Bidens pilosa Linn and Dichrostachys cinerea Wight et Arn extracts against common diarrhoea-causing waterborne bacteria. Bidens pilosa and Dichrostachys cinerea extracts were investigated for the antibacterial properties against waterborne diarrhoeagenic bacteria.The plant materials were extracted using the direct and serial exhaustive methods using solvents of varying polarities, namely, hexane, dichloromethane, ethyl acetate, acetone and methanol

2018 BMC Complementary and Alternative Medicine

167. A traumatic hepatic artery pseudoaneurysm and arterioportal fistula, with severe diarrhea as the first symptom: A case report and review of the literature. Full Text available with Trip Pro

using coils. Since a secondary feeding vessel was exposed after the first embolization of the main feeding artery, a less-selective embolization was performed again.During the 6-month follow-up period, the patient remained asymptomatic.A penetrating abdominal stab wound is a rare cause of hepatic APFs, and occasionally leads to portal hypertension, the medical history and physical examination are the most important cornerstones of clinical diagnosis. Interventional radiology is essential (...) A traumatic hepatic artery pseudoaneurysm and arterioportal fistula, with severe diarrhea as the first symptom: A case report and review of the literature. Hepaticarterioportal fistula (APF) is a rare cause of portal hypertension and gastrointestinal hemorrhage, and presents as abnormal communication between the hepatic artery and portal vein. Percutaneous liver biopsy is a main iatrogenic cause of AFP. However, non-iatrogenic, abdominal, trauma-related APF is rarely reported.A 29-year-old man

2018 Medicine

168. Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth

of a placebo powder for 24 weeks. Outcome Measures Go to Primary Outcome Measures : Incidence of diarrhea [ Time Frame: Incidence over the 24-week follow-up period ] Incidence of diarrhea is defined as the number of diarrheal episodes per person-weeks of follow-up Change in length-for-age Z score [ Time Frame: Measured at enrollment and the end of the 24-week follow-up period ] Change in length-for-age Z score from enrollment to the end of the 24-week follow-up period Secondary Outcome Measures : Change (...) to support growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children but, the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP) on child growth and diarrheal disease are mixed and pose programmatic

2018 Clinical Trials

169. Efficacy Of Probiotics vs. Zinc vs. Probiotics-Zinc Combination On Acute Diarrhea In Children

Chart" Secondary Outcome Measures : Diarrhea duration [ Time Frame: Till the end of diarrhea, an average of five days ] duration of diarrhea in days Hospital stay [ Time Frame: Till the end of diarrhea, an average of four days ] Length of hospital stay in days Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn (...) of zinc to the standard treatment. The third group will be managed by the addition to a combination of zinc and probiotics to standard treatment. The patients will be followed to compare the effect of the given medication on the duration of diarrhea. Condition or disease Intervention/treatment Phase Acute Diarrhea Other: Probiotics Other: Zinc Other: Probiotics & Zinc Other: Standard care Not Applicable Detailed Description: This is a prospective, randomized, double blinded, clinical trial

2018 Clinical Trials

170. Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients

calculation via nasojejunal tube. Active Comparator: Osmolite 1.5 Higher osmolality enteral tube feed formulation Other: Osmolite 1.5 Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube. Outcome Measures Go to Primary Outcome Measures : Incidence of diarrhea at 72 hours [ Time Frame: 72 hour ] Secondary Outcome Measures : Incidence of diarrhea at 14 days [ Time Frame: 14 days ] Mean frequency of diarrhea days [ Time Frame: 14 days ] Total number of diarrhea days (...) of an ileostomy or colostomy History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487744 Locations Layout table for location information United States, Utah

2018 Clinical Trials

171. A Study Evaluating Bacillus Cereus in the Prevention of Afatinib-associated Diarrhea

by the NCI CTCAE, version 4.03 and recorded as AEs in the eCRF Proportion of subjects taking anti-diarrheal medication [ Time Frame: Up to 4 weeks ] Proportion of subjects taking anti-diarrhoeal medication as recorded in the eCRF Proportion of subjects with AEs and SAEs [ Time Frame: Up to 4 weeks ] Proportion of subjects with AEs and SAEs were assessed from the start of the study until end of study as recorded in the eCRF Other Outcome Measures: Overall Response Rate [ Time Frame: Up to 4 weeks (...) , or dosage reduction. Currently, no prophylactic measure was demonstrated efficaciously. Bacillus cereus is an aerobic spore-forming bacterium that is commonly found in soil. The efficacy of Bacillus cereus in the management of afatinib treatment-associated diarrhoea has not been extensively evaluated in clinical studies. This is a single-arm, single-institutional, phase II study evaluating the efficacy and safety of Bacillus cereus (Changfukang®) in the prevention of afatinib-associated diarrhea

2018 Clinical Trials

172. Changes in Microbiota and Metabolomic Profile Between Rifaximin Responders and Non-responders In Diarrhoea-Predominant Irritable Bowel Syndrome

enterocolitica, Campylobacter jejuni, Salmonella, Shigella, ovum and parasites, and/or Clostridium difficile Subject who has psychiatric disorders which are not controlled ("controlled" is based on the Investigator's medical judgment); subjects with psychoses are excluded regardless of current therapy. Subject has current or recent history (within 12 months before signing informed consent) of drug, laxative or alcohol abuse Subject is pregnant or lactating Subject has a history of human immunodeficiency (...) explore the oral microbiome in IBS patients, and assess its relationship with fecal microbiome between responders and non-responders. Condition or disease Intervention/treatment Phase Irritable Bowel Syndrome With Diarrhea Drug: Rifaximin Oral Tablet Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 50 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science

2018 Clinical Trials

173. TReatment of Irritable Bowel Syndrome With Diarrhoea Using Titrated ONdansetron Trial

diarrhoea (SeHCAT results of > 10% or C4 results of <19 ng/ml), Note: Cholecystectomy will not be an exclusion criteria if bile acid diarrhoea has been excluded Lactose malabsorption. Coeliac disease (tTG or duodenal biopsy) All patients must agree to use methods of medically acceptable forms of contraception during the study and for 90 days after completion of study drug, (e.g. implants, injectable, combined oral contraceptives, True abstinence (when this is in line with the preferred and usual (...) provided by University of Leeds: Diarrhoea Additional relevant MeSH terms: Layout table for MeSH terms Syndrome Diarrhea Irritable Bowel Syndrome Disease Pathologic Processes Signs and Symptoms, Digestive Signs and Symptoms Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipruritics Dermatologic Agents

2018 Clinical Trials

174. Oral Administration of Tannins and Flavonoids vs Sacchaomyces Boulardii in Pediatric Acute Diarrhea

population of children affected by AG in terms of duration of diarrhea Condition or disease Intervention/treatment Phase Diarrhea Acute Gastroenteritis Acute Diarrhea Device: Actitan-F Drug: Saccharomyces Boulardii 250 MG Oral Powder Other: Dicodral 60 Phase 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 160 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary (...) Purpose: Treatment Official Title: A Prospective Randomized-controlled Trial on Efficacy of Oral Administration of Tannins and Flavonoids and Standard Oral Rehydration (SOR) vs Saccharomyces Boulardii and SOR in Treatment of Pediatric Acute Diarrhea Estimated Study Start Date : December 2018 Estimated Primary Completion Date : December 2019 Estimated Study Completion Date : March 2020 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm

2018 Clinical Trials

175. Point-of-Use Pathogen Identification Tool for Diarrhea

. This may make it easier for health care workers to more quickly fight diarrheal diseases. Objective: To test a tool that may detect what germs cause diarrhea. Eligibility: People already enrolled in an active NIH protocol who have diarrhea Design: Participants will have 1 or 2 studies. They will give information about their symptoms, current medicines, and basic personal data. They will give a stool sample. Part of each sample will be tested in a lab. The rest will be stored indefinitely. No personal (...) pathogen testing using the NIH standard of care, BioFire FilmArray GI Pathogen Panel (FDA approved PCR based pathogen diagnostic) by the Department of Laboratory Medicine (DLM) is indicated. Collected stool samples will be tested for pathogens causing GI disease, using the FilmArray GI panel by the DLM. Technicians in the NINR laboratories will test aliquots from the same stool samples using our tool. The tool has been designed for detection of the most common diarrhea causing pathogens. Of primary

2018 Clinical Trials

176. Community Mobilization and Incentivization for Childhood Diarrhea and Pneumonia

Primary Completion Date : July 31, 2020 Estimated Study Completion Date : October 30, 2020 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Community Mobilization This arm will receive specific messages regarding the prevention and management of childhood diarrhea and pneumonia. The investigators will form village committees (VC) consisting of prominent members of the community (6-8 in a group) to carry (...) : July 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Additional relevant MeSH terms: Layout table for MeSH terms Pneumonia Diarrhea Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms, Digestive Signs and Symptoms

2018 Clinical Trials

177. Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea

administration) in the acquisition of travelers diarrhea and the acquisition of antimicrobial resistance genes. Other Name: Pepto Bismol Placebo Comparator: Placebo Placebo oral tablet 4 bid Drug: Placebo Oral Tablet Placebo manufactured to mimic pepto bismol Outcome Measures Go to Primary Outcome Measures : Traveler's diarrhea [ Time Frame: Change from baseline through 10 days post-travel ] Self-reported TD Secondary Outcome Measures : Gut AMR genes [ Time Frame: Once within 7 days (before travel); once (...) : Centers for Disease Control and Prevention Collaborators: Procter and Gamble New York Center for Travel and Tropical Medicine Information provided by (Responsible Party): Kristina Angelo, Centers for Disease Control and Prevention Study Details Study Description Go to Brief Summary: The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate (BSS) has an effect on the acquisition of travelers' diarrhea (TD) or antimicrobial resistance (AMR) genes in fecal samples among

2018 Clinical Trials

178. Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea

Last Update Posted : August 20, 2018 Sponsor: Omnifarma Kiev LLC Information provided by (Responsible Party): Omnifarma Kiev LLC Study Details Study Description Go to Brief Summary: The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea. Condition or disease Intervention/treatment Phase Diarrhoea;Acute Drug: Carbowhite Drug: Carbowhite placebo Phase 2 Detailed Description: Background (...) -180 First Posted: August 16, 2018 Last Update Posted: August 20, 2018 Last Verified: August 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: No Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Keywords provided by Omnifarma Kiev LLC: Diarrhoea Carbowhite Colloidal silicon dioxide Additional relevant MeSH terms: Layout table for MeSH terms Diarrhea Signs and Symptoms, Digestive Signs

2018 Clinical Trials

179. Effect of a multispecies probiotic on reducing the incidence of antibiotic-associated diarrhoea in children: a protocol for a randomised controlled trial. Full Text available with Trip Pro

, up to a maximum of 17 days. The primary outcome will be the incidence of AAD, defined as ≥3 loose or watery stools (a score of A on the Amsterdam Infant Stool Scale or a score of 5-7 on the Bristol Stool Form scale) in 24 hours, caused either by Clostridium difficile or of otherwise unexplained aetiology, occurring during the intervention period. The secondary outcomes will include the incidence of AAD according to alternative definitions; the incidence of any kind of diarrhoea; the duration (...) of diarrhoea; the need for hospitalisation; intravenous rehydration or discontinuation of antibiotic treatment due to diarrhoea; adverse events; and the intestinal microbiota composition.The study protocol is approved by the Ethics Committee of the Medical University of Warsaw. The findings will be published in a peer-reviewed journal and submitted to relevant conferences.14/10/2017.NCT03334604; Pre-results.© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018

2018 BMJ open

180. Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant

Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before (...) adding more. Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant (DIETSINIBS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03423069 Recruitment Status : Recruiting First Posted : February

2018 Clinical Trials

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