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Constipation clinical trials

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NCT ID: NCT05240521 Recruiting - Clinical trials for Irritable Bowel Syndrome With Constipation (IBS-C)

Efficacy and Safety, Tolerability of GA-AT0119 in IBS-C

RELAX
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is a common functional bowel disorder that imposes a considerable burden on health-related quality of life (QOL) worldwide. Irritable Bowel Syndrome (IBS) is a common digestive disorder affecting 7-21% of the general population. IBS with predominant constipation (IBS-C) is a subtype of IBS that accounts for more than a third of the IBS diagnosed. The study Sponsor, Devintec SAGL, presents GA-AT0119, which acts by forming a mechanical barrier on the intestinal mucosa thanks to xyloglucan and pea proteins avoiding the increased intestinal permeability, bacterial invasion to intestinal tissues, and subsequent intestinal inflammation. The formulation of GA-AT0119 is completed with chia seed powder which provides a laxative effect by retaining water in the intestine increasing stool bulk and accelerating fecal transit. There is increasing evidence that the pathophysiology of IBS is multifaceted involving mucosal inflammation, visceral hypersensitivity, microbial dysbiosis, dietary factors, and altered intestinal permeability (IP). Several studies have shown increased intestinal permeability in patients with irritable bowel syndrome. Serum zonulin, a biomarker of impaired increased permeability, is increased in patients' constipation-predominant irritable bowel syndrome compared to a healthy population and the levels are comparable to celiac disease.

NCT ID: NCT05216328 Recruiting - Clinical trials for Constipation, Opioid-Induced

Prevention of Opioid-induced Constipation in Patients With Advanced Cancer

OMAMA
Start date: December 2, 2022
Phase: Phase 4
Study type: Interventional

More than 70% of patients with cancer in the palliative phase have pain that often requires treatment with opioids (morphine-like agents). Constipation occurs in 59% of patients treated with opioids. Opioid-induced constipation (OIC) has consequences that range from daily discomfort with social insecurity and disability to intestinal obstruction. It leads to limitations in self-management, a reduced quality of life and a risk of the need for more care. In the guideline "Diagnosis and treatment of pain in patients with cancer" it is recommended to start preventively with an osmotic laxative such as macrogol/electrolytes or magnesium hydroxide when starting opioids. Macrogol/electrolytes has been proven to be effective for OIC, but is sometimes perceived by patients as unpleasant due to its taste. Magnesium hydroxide, which is less commonly prescribed for OIC, has a neutral taste. Although it is mentioned in the guideline, it is not studied for the treatment of OIC and also not officially registered for this. To support the advice of the guideline and to prove that a choice is possible, it is important to investigate whether there are differences in effectiveness and/or side effects between macrogol/electrolytes and magnesium hydroxide in the prevention of OIC. The aim of this study is to compare macrogol/electrolytes with magnesium hydroxide in the prevention of opioid-induced constipation in patients with cancer in the palliative (incurable) phase, who start opioids because of pain. The choice of laxative is determined by drawing lots (randomisation). After two weeks, its effect will be assessed and will be presented as the percentage of patients who have not developed constipation after starting opioids. If the laxative, as assigned by lot, is described as satisfactory by the patient, the patient can continue with the drug that the patient used, after the study through regular prescription. The investigators will ask the patients in the study about their satisfaction with the laxative used, any side effects and the degree of pain. Furthermore, the appeal to care for possible constipation will be examined. Because the best attainable quality of life in the palliative phase is the objective of all care, the investigators will also measure this perceived quality with a questionnaire in this study. The results of this study will lead to the best achievable prevention of opioid constipation in patients with cancer in the palliative phase.

NCT ID: NCT05192317 Recruiting - Clinical trials for Chronic Constipation

Administration of a Natural Molecular Complex in Functional Chronic Constipation

Start date: November 9, 2021
Phase: N/A
Study type: Interventional

This is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation. Treatment period for each patient is 28 days.

NCT ID: NCT05165199 Recruiting - Clinical trials for Chronic Constipation

Elobixibat for Chronic Constipation Without Defecation Desire

R-LODD
Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.

NCT ID: NCT05157061 Recruiting - Clinical trials for Irritable Bowel Syndrome

GOS to Reduce Symptom Severity in IBS

EGIS
Start date: October 26, 2021
Phase: N/A
Study type: Interventional

IBS is a highly prevalent bowel disorder, characterized by recurrent abdominal pain during bowel movements or a change in bowel habits. Typically, IBS patients experience constipation, diarrhoea or a mix of constipation and diarrhoea, as well as symptoms of abdominal bloating or distension. The chronic and bothersome nature of IBS symptoms negatively affects the quality of life of many patients. Because there are currently limited medical treatment options for IBS, it is important to study new treatments. IBS can (in part) be caused by an 'imbalance' of the bacteria residing in the intestinal tract. For instance, there may be a lower proportion of specific bacteria that are generally considered beneficial for a persons health. The consumption of non-digestible food ingredients, such as GOS, may stimulate the growth of these beneficial bacteria. GOS is a type of 'prebiotic', which is known to support health and wellbeing of consumers. By restoring the bacterial balance of the intestinal tract, the symptoms of IBS may be reduced after consumption of GOS. The health effects of the study product (a specific GOS) used in current study was previously investigated in a small group of patients with IBS. Use of the study product indicated a reduction in the patients' symptoms, improvement in the patients' quality of life, and changes in patients' gut bacteria. It is therefore hypothesized that GOS / a specific GOS may reduce the symptom severity of patients with IBS. This study further evaluates how GOS may improve symptoms of IBS.

NCT ID: NCT05149833 Recruiting - Clinical trials for Opioid-Induced Constipation

European Study of Opioid Induced Constipation

E-StOIC
Start date: September 16, 2021
Phase:
Study type: Observational [Patient Registry]

Constipation is common (40-90%) in advanced cancer patients , and has a significant negative impact on quality of life. The aetiology of constipation is often multifactorial in advanced cancer patients. However, it is well recognised that opioid analgesics are a common cause of constipation in this group. The prevalence of opioid-induced constipation (OIC) is stated to be 40-70%, although a recent large study reported an even higher figure. OIC has been reported to exceed pain in terms of distress caused, and studies have found that some patients choose to reduce or discontinue opioid medication in order to attempt to better control constipation. Moreover, OIC is associated with a variety of physical (gastrointestinal, systemic), psychological and social problems.

NCT ID: NCT05137145 Recruiting - Bowel Preparation Clinical Trials

Effect and Safety of Polyethylene Glycol Combined With Linaclotide on Colon Cleansing for Patients With Chronic Constipation

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Constipation is a common reason of poor bowel preparation, which negatively influences the quality of colonoscopy. Clinically to explore more effective and tolerant bowel clearance programs is necessary for patients with chronic constipation.

NCT ID: NCT05134584 Recruiting - Clinical trials for Functional Dyspepsia

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Start date: January 1, 2021
Phase: Phase 4
Study type: Interventional

This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).

NCT ID: NCT05133076 Recruiting - Clinical trials for Opioid-Induced Constipation

Safety and Preliminary Efficacy of BGP345A in Constipation Due to Opioid-based Medications

OIC1
Start date: January 20, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non cancer pain.

NCT ID: NCT05037565 Recruiting - Constipation Clinical Trials

Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents

Start date: January 2022
Phase: N/A
Study type: Interventional

Partially hydrolyzed guar gum (PHGG) is a vegetal, water soluble, non-viscous, non-gelling dietary fiber that is derived from guar gum, a water-soluble, viscous, gelling polysaccharide found in the seeds of Cyamopsis tetragonolobus. PHGG is food for special medical purpose and available over-the-counter. It is as effective as lactulose treatment in relieving constipation associated abdominal pain in children. Up-to-date, there is no randomized study regarding the effectiveness of PHGG in reducing constipation in long term care facility residents, the investigator therefore would like to perform a prospective, randomized study to assess its effectiveness in long term care facility residents to improve fecal characteristics and its effect on use of laxative agents.