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Diarrhea clinical trials

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NCT ID: NCT02414399 Active, not recruiting - Malaria Clinical Trials

Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children

Toto Bora
Start date: June 28, 2016
Phase: Phase 4
Study type: Interventional

Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital. These children represent an accessible high-risk population in which targeted interventions to prevent morbidity and mortality could have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated communities. However, mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance within treated communities and is expensive. The targeted delivery of azithromycin to children at hospital discharge may be a novel and practical intervention to maximize benefit while minimizing risk of antibiotic resistance. This is a randomized, double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at discharge, compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59 months in Kenya. The study will also investigate potential mechanisms by which azithromycin may reduce morbidity and mortality in this population and will assess the emergence of antibiotic resistance among treated individuals and their primary caregivers. A cost-effectiveness analysis of the intervention will also be conducted.

NCT ID: NCT02400476 Completed - Clinical trials for Early Stage HER2+ Breast Cancer

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide

Start date: February 2015
Phase: Phase 2
Study type: Interventional

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic measures.

NCT ID: NCT02396407 Completed - Diarrhea Clinical Trials

Spillover Effects of Water, Sanitation, and Hygiene Interventions on Child Health

Start date: January 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to measure whether a combined water, sanitation, and hygiene intervention leads to improved health of children who did not receive the intervention themselves and who live within a close vicinity of intervention recipients.

NCT ID: NCT02385773 Completed - Diarrhea Clinical Trials

Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease

Start date: March 2015
Phase: N/A
Study type: Interventional

This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will enroll children between the ages of 6 months and 3 years and will assess the impact of the study nutrition product on the duration and severity of diarrhea and on weight recovery in the 4 weeks following the diarrheal episode. The investigators will be determining the etiology of the diarrhea episode to ascertain if the nutritional product works better for certain etiologies or has a non-specific benefit.

NCT ID: NCT02383810 Completed - Clinical trials for Drug and/or Toxin-induced Diarrhea

Dose Finding Study in Colorectal Cancer Patients Receiving 5-FU-based Chemotherapy to Assess the Efficacy of Elsiglutide in the Prevention of Chemotherapy Induced Diarrhea (CID)

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, stratified, double-blind, double-dummy, parallel group, placebo-controlled, dose finding, multicentre, multinational, phase II study in patient with colorectal cancer receiving 5- Fluorouracil (5-FU)-based chemotherapy (FOLFOX or FOLFIRI). Patients will receive, starting from the day of chemotherapy administration, a single daily dose subcutaneously (s.c.) of elsiglutide 10, 20 or 40 mg or placebo for 4 consecutive days. Each patient will be in the study for 3 consecutive chemotherapy cycles. The treatment period for each patient will be 4 consecutive days at each of the first 2 chemotherapy cycles. The primary objective is to compare the efficacy of 3 s.c. doses of elsiglutide versus (vs.) placebo and vs. each other dose in the prevention of CID in colorectal cancer patients treated with 5-FU based chemotherapy (FOLFOX or FOLFIRI) with no addition of a monoclonal antibody.

NCT ID: NCT02381405 Terminated - Diarrhea Clinical Trials

A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®)- for Maintaining Bowel Regularity in Patients With GI Toxicity From Any Combination of Therapy Including Tyrosine Kinase Inhibitors (TKI)

Start date: February 2015
Phase: N/A
Study type: Interventional

This is an open label, randomized investigation of a proprietary blend of amino acids, called Enterade®, and its effect on irregularity (diarrhea) caused by radiation therapy and/or chemotherapy including TKI*. Subjects will be randomized to receive Enterade® or continue standard of care. Two patients will be enrolled on the treatment arm for each patient on the control arm.

NCT ID: NCT02374580 Completed - Malaria Clinical Trials

Partnership and Dignity: a Mixed-methods Survey on Supporting and Retaining Uganda's Village Health Teams

Start date: February 2015
Phase: N/A
Study type: Observational

For more than a decade, Uganda's Ministry of Health has led a community health worker program model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the task of delivering preventative health services and education to their local communities. Studies have demonstrated the effectiveness of Uganda's VHTs in improving certain health outcomes; however it is known that VHTs are not optimally supported, and there has been VHT attrition in recent years. The Ministry of Health has recognized the inadequate support of VHTs thus far and is aiming to "expand VHTs to all local governments and explore ways of sustaining VHTs." The objective of this study is to evaluate the extent to which material support is a deciding factor in the efficiency and durability of Uganda's VHT initiative. Material support may take the form of monetary stipends, regular payment, transportation assistance, or nonfinancial materials such as bicycles or mobile phone airtime. This study will review existing literature and gather novel data through surveys of VHT members and VHT stakeholders. The quantitative and qualitative survey data will be analyzed for trends that may point to a conclusion in the context of existing health policy discourse on community health worker remuneration. The purpose of this study is to strengthen the knowledge base on whether or not the current absence of material support significantly limits the potential for Uganda's VHTs to be sustained and expanded. This information can be used by governmental and non-governmental organizations in their work to strengthen and sustain VHTs throughout the country.

NCT ID: NCT02362932 Completed - Diarrhea Clinical Trials

The Effect of an Urban Sanitation Intervention on Child Health

MapSan
Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the health impact of a basic sanitation intervention in Maputo, Mozambique.

NCT ID: NCT02358694 Completed - Clinical trials for Diarrhea Predominant Irritable Bowel Syndrome

Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS

Start date: June 15, 2014
Phase: N/A
Study type: Interventional

This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D. Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.

NCT ID: NCT02340481 Completed - Diarrhea Clinical Trials

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence

Start date: July 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of combined loperamide hydrochloride and simethicone compared to loperamide hydrochloride monotherapy in treating acute diarrhea associated with abdominal discomfort caused by gastrointestinal gas accumulation.