Efficacy and Safety of a Food Supplement With Standardized Menthol, Limonene, and Gingerol Content...
Irritable Bowel SyndromeIrritable Bowel Syndrome With Diarrhea2 moreThe purpose of this study is to assess the efficacy and safety of a food supplement with standardized menthol, limonene, and gingerol content in patients with irritable bowel syndrome (IBS) or IBS/functional dyspepsia (FD).
Study of LRG-002 Hard Capsules (Lek d.d., Slovenia) Used in the Prophylaxis of Antibiotic-associated...
Antibiotic-associated DiarrheaThe goal of this study was to investigate the efficacy and safety of LRG-002 investigational medicinal product, capsules (Lek d.d., Slovenia) in comparison with placebo, as an adjunct treatment for prophylaxis of antibiotic-associated diarrhea (AAD) in patients with acute respiratory diseases (ARDs) receiving a standard antimicrobial therapy.
Comparative Evaluation of Herbal and Allopathic Drugs for the Treatment of Chronic Diarrhea
Chronic DiarrheaRevival of significance and the emergent market of herbal medicinal products necessitate strong commitment by the stakeholders to safeguard the end users. The variability in the concentrations of constituents of plant material, coupled with the variety of extraction techniques and processing steps used by different manufacturers, results in distinct inconsistency in the quality of herbal products. The present study will be directed to a polyherbal formulation Entoban which integrates an outstanding blend of herbs that have been used for decades to eradicate microorganisms and worms from gastrointestinal tract. It is the combination of Holarrhena antidysenterica, Berberis aristata, Symplocos racemosa, Querecus infectoria and Helicteres isora. The current study would target the chemical assessment, pharmacological and comparative clinical evaluation of Entoban to assure its safety and efficacy.
Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal...
DiarrheaThis 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.
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin...
Clostridium Difficile-associated Diarrhea (CDAD)The purpose of this study was to investigate the clinical response to fidaxomicin oral suspension or tablets and vancomycin oral liquid or capsules in pediatric participants with Clostridium difficile-associated diarrhea (CDAD). It also investigated the recurrence/sustained clinical response to and safety of fidaxomicin and vancomycin, as well as acceptance of the fidaxomicin oral suspension formulation.
Lysine Trial in Adults With Diarrhoea
DiarrheaDiarrhea as of today is still a major problem in developing world with high morbidity. Though mortality in under-5 children has declined over the years, diarrhea was responsible for 2.5 million deaths per year in developing countries. A median of 3.2 episodes of diarrhea in under-5 children per child-year has been estimated in developing countries. In Bangladesh, the overall prevalence of diarrhea was estimated to be about 2% for the entire population. However, a recent survey in 2003 with urban slum mothers indicated that the prevalence of diarrhea ranged from 0.7-4.1% in six divisional cities with 0.7% in Dhaka slum areas. Malnutrition remains the major adverse prognostic indicator for diarrhea related morbidity, which emphasizes importance of nutrition in early management. Repeated episodes of diarrhea are a frequent cause and consequence of malnutrition. To improve diarrhea situation in Bangladesh and elsewhere, interventions are directed to reduce mortality and morbidity through improvement of breast-feeding practices, complementary feeding, sanitation, increase in measles immunization rates, micronutrient supplementation, and oral rehydration therapy. L-lysine, an essential amino acid, is required for healthy growth, tissue repair and enzyme production. It is a protein-building block that strengthens and nourishes the structural, circulatory and immune systems. It is not produced by the body like other essential amino acids and must be obtained from the diet. Some natural food sources for L-lysine include Lima beans, kidney beans, potatoes, corn, red meat, fish and milk. The mean requirement of lysine in healthy human adults is about 30 mg/kg body weight/day or 50 mg/g protein intake. Studies have shown that lysine therapy improves immune status and is used as a therapeutic agent in herpes simplex viral infection. A double-blind randomized trial of L-lysine treatment found it to be an effective agent for significant reduction in occurrence, severity and healing time for recurrent herpes simplex viral infection. Lysine fortification increased the blood levels of complement 3 (C3), CD-4 and CD-8 T-cells as compared with controls. These two studies suggest that supplementation of lysine through food fortification enhances immunological status. A few recent studies have also shown an effect of lysine on diarrheal incidence and severity. An experimental model suggested inhibitory effect of L-lysine on incidence of diarrhea induced by stress and 5-hydroxytryptamine. A community trial among adults in Syria showed that the period prevalence and mean duration of diarrheal illness were significantly lower in the female participants who consumed lysine-fortified wheat bread compared to the control group as well as better immunological parameters such as C3c delta. The proposed study will observe the impact of a daily dose of 2000 mg supplemental L-lysine for 6 months on diarrheal illness in an adult population of an urban slum area in Dhaka whose principal diet is based on cereals such as rice and or wheat. The daily protein and lysine availability from diets of Bangladeshi population has been calculated to be about 43g and 1883 mg respectively, compared to 113g and 7,598 mg respectively in the USA. This means that 2000 mg daily supplementation of L-lysine would not pose any detrimental effect, as the combined usual and supplemental intake will still be substantially lower compared to the intake in USA. However, as expected, the supplemental L-lysine may reduce the incidence and severity of diarrheal illness through improvement of the nutritional and immunological status of the study population. The investigators propose to conduct a community-based, double-blind randomized controlled trial in Mirpur area of Dhaka city. Adults aged 18 to 45 years residing in the catchment area for at least the last six months will be eligible for the study. A total of 440 subjects (220 females) will be enrolled. The results of the proposed study will contribute to our existing knowledge of the effect of lysine on incidence and severity of diarrheal illness as well as on immune status. A positive impact of lysine supplementation on diarrheal illness may lead to a future strategic approach to the control of diarrhea as a global public health problem.
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant...
Diarrhea-predominant Irritable Bowel SyndromeTo demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).
A Study of Ascending Single Doses of Surotomycin in Healthy Participants (MK-4261-008)
Clostridium Difficile Associated Diarrhea (CDAD)This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of a single oral dose of surotomycin (CB-183,315) at ascending dose levels when given to healthy males and females.
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
Irritable Bowel Syndrome With DiarrheaIrritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant...
Irritable Bowel SyndromeThe objective of this study is to evaluate the safety and efficacy of LX1033 over a range of dose levels in subjects with diarrhea-predominant Irritable Bowel Syndrome (IBS).