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Diarrhea clinical trials

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NCT ID: NCT06193408 Recruiting - Cholera Clinical Trials

Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera

Start date: February 11, 2024
Phase: Phase 2
Study type: Interventional

Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens

NCT ID: NCT06179589 Completed - Clinical trials for Acute Watery Diarrhoea

VS002A in the Treatment of Acute Watery Diarrhea in Infants and Young Children

Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Background (brief): 1. Burden: Diarrhea is the second deadliest disease for under-five children globally and the situation is more serious in developing countries. It was responsible for 688 million illnesses and 499,000 deaths worldwide in children less than 5 years of age in 2015 (Kotloff, 2017). Majority of the deaths from diarrhea occur before the second birthday of the children and it contributes to more than 20% of overall death in infants and young children. 2. Knowledge gap: Oral rehydration solution (ORS) is being used as a standard treatment for acute watery diarrhea for long time and which is one of the best inventions in the history of medicine. The ORS currently recommended by the WHO/UNICEF contains glucose, sodium chloride, potassium chloride, and tri-sodium citrate dehydrate, which is optimal for rehydration of patients of all ages with dehydration from acute diarrhea of any aetiology. However, oral rehydration therapy (ORT) with the present ORS formulation has certain limitations - it does not reduce the volume, frequency or the duration of diarrhea. Additionally, the failure of present standard ORS to reduce dramatically stool output likely contributes to the relatively limited use of ORS by mothers as they do not feel that ORS is helping their child from the episode of diarrhea. Thus, it warrants the development of newer and improved formulation of ORS to become more effective against diarrhea. 3. Relevance: It has been reported that the glucose contained in standard ORS may fail to absorb fluid and electrolytes adequately from gut and worsen diarrhea in different patho-physiological ways as the present WHO ORS is hypo-osmolar. Whereas, certain neutral amino acids (e.g. glycine, L-alanine, L-glutamine) are able to enhance the absorption of sodium ions and water from gut. By using this concept, the University of Florida (UF), developed a sugar-free, shelf-stable amino acid-based hydration medicinal food named 'VS002A' that effectively rehydrates, and improves barrier function of the bowel following infections targeting the gastrointestinal tract. So, the investigators ought to know whether VS002A will be superior or not to WHO-ORS in the treatment of acute non-cholera watery diarrhea in infants and young children. Hypothesis (if any): The amino acid-based ORS "VS002A" will reduce duration of non-cholera watery diarrhea in infants and young children when compared to treatment with standard WHO-ORS. Objectives: To compare the efficacy of amino acid-based ORS "VS002A" compared to standard Glucose-based WHO ORS in infants and young children suffering from acute non-cholera watery diarrhea. Methods: - It will be a randomized, double-blind, two cell clinical trial at Dhaka Hospital of icddr,b. Total 312 (156 in each arm) male children aged 6-36 months old with acute (onset <48 hours) non-bloody watery diarrhea will be included in this study. However, patients with severe malnutrition, any systemic illness, cholera, unwilling to comply with study protocol, remain significantly dehydrated 4 hours after intravenous fluid infusion (if required at start), has documentation of taking antibiotics or antidiarrheal 48 hours before admission will be excluded. - Intervention arm participants will get amino acid ORS (VS002A) and control arm will get standard glucose based WHO-ORS. Other aspects of clinical managements for diarrhea as per hospital guideline will be similar in both cases and controls

NCT ID: NCT06153420 Recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Study of the Research Medicine CIN-103 in Adults With Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D).

Start date: December 28, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate if the study drug, CIN-103, can help reduce the symptoms associated with irritable bowel syndrome with predominant diarrhea (IBS-D) in adult patients. The main questions it aims to answer are: - To evaluate the efficacy of CIN-103 on symptoms of IBS-D when given to patients with IBS-D compared to a placebo. - To evaluate the safety and tolerability of CIN-103 when given to patients with IBS-D compared to a placebo Participants will attend the following visits: - Screening Period (1 Visit) - Baseline Period (1 Visit) - Will complete daily diary and other Patient Reported Outcomes (PROs) as described in the protocol to assess eligibility for continued participation. - 12-Week Treatment Period (5 Visits) - Study drug taken twice daily by mouth. - Will complete daily diaries and other PROs as described in the protocol. - Follow- Up Period (1 Visit) Researchers will compare CIN-103 Dose 1, CIN-103 Dose 2, and placebo, to evaluate the clinical response to multiple dose strengths of CIN-103 relative to placebo on abdominal pain and stool consistency along with safety and tolerability.

NCT ID: NCT06152471 Recruiting - Diarrhea Clinical Trials

Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer

ASF-BC
Start date: June 7, 2023
Phase: Phase 3
Study type: Interventional

The present study aims to investigate a proactive strategy including Salovum™ and SPC-flakes to prevent the occurrence of abemaciclib-induced diarrhea in patients with early breast cancer.

NCT ID: NCT06152289 Recruiting - Crohn Disease Clinical Trials

Development of New Diagnostic Tools in Capsule Endoscopy

NOCE
Start date: February 10, 2023
Phase:
Study type: Observational

Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

NCT ID: NCT06150287 Not yet recruiting - Clinical trials for Renal Transplantation

Effect of Probiotics on Immunosuppressive-drug-associated Diarrhea Among Renal Transplant Recipients

Start date: December 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. The main questions it aims to answer are: 1. Does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea? 2. Does probiotics effective in reducing inflammation? 3. Is there any connection between fecal microbiome and immunological markers? Participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. Researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.

NCT ID: NCT06149715 Enrolling by invitation - Diarrhea Clinical Trials

Water Filter Study in Ciudad Victoria

Start date: January 20, 2024
Phase: N/A
Study type: Interventional

This study measures effects of water filters and filter types on household health in Ciudad Victoria, Mexico.

NCT ID: NCT06125626 Completed - Diarrhea Clinical Trials

Prevention of Traveler's Diarrhea

Start date: July 10, 2023
Phase: Phase 2
Study type: Interventional

The prevention of traveller's diarrhea makes use of the selection of foods and drinks, the purification of water, the use of pharmacological substances such as bismuth salicylate and rifaximin (which can only be taken for short periods). The very attractive prospect of preventing travellers' diarrhea without systemic antibiotics has fueled interest in probiotics for this purpose. However, not all probiotics are identical, and the results of studies conducted with a particular agent cannot be generalized to indicate that any probiotic agent would be successful in the same clinical situation. Probiotics such as Lactobacillus GG have been shown to reduce the incidence of diarrhea in travelers in randomized controlled trials. In contrast, another Lactobacillus preparation, non-viable Lactobacillus acidophilus, showed no benefit over placebo in a randomized, double-blind, controlled trial of 174 travelers. The reasons for this are unclear, but could be related to the fact that the bacteria were not viable or a peculiarity of the strain selected for testing.

NCT ID: NCT06123234 Recruiting - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Randomised Double-blind Active vs. Placebo Clinical Trial on the Effect of a Food Supplement on IBS-D in Children

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a food supplement in children of 3-12 years with IBS-D. The main questions it aims to answer are: - Is the tested supplement able to improve and/or reduce IBS-related symptoms? - After administration of the food supplement, how does the state of intestinal inflammation improve? - Is the gut microbiota modified? Participants will take the food supplement every day for 2 months. After 30 days and after 60 days, they will be visited from the gastroenterologist. - They have to fill in the questionnaire and the symptom's diary weekly and deliver it to the gastroenterologist during the visits - At the first visit, they will collect the faecal sample for the analysis of inflammatory markers and gut microbiota - After 30 days, they will collect the faecal sample for the analysis of inflammatory markers - After 60 days, they will collect the faecal sample for the analysis of gut microbiota Researchers will compare with placebo to see if the product is effective.

NCT ID: NCT06109740 Completed - Critical Illness Clinical Trials

Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit

Start date: October 2008
Phase: N/A
Study type: Interventional

The goal of this prospective trial is to learn about lactobacillus use in critically ill pediatric patients. The main question[s] it aims to answer are: - Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU - Is lactobacillus safe in critically ill pediatric patients Participants will be randomized to lactobacillus GG vs placebo while on antibiotics If there is a comparison group: Researchers will compare lactobacillus GG to see if it prevents antibiotic associated diarrhea.