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Constipation clinical trials

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NCT ID: NCT06351995 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Neostigmine and Glycopyrrolate by Iontophoresis

Start date: November 6, 2020
Phase: Phase 3
Study type: Interventional

To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis.

NCT ID: NCT06351852 Recruiting - Clinical trials for Spinal Cord Injuries

Transdermal Administration by a Novel Wireless Iontophoresis Device

Start date: March 22, 2022
Phase: Early Phase 1
Study type: Interventional

Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE). The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis). The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation.

NCT ID: NCT06349031 Not yet recruiting - Clinical trials for Functional Constipation

Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction

Start date: April 15, 2024
Phase: Phase 4
Study type: Interventional

Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements. Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction. Present study has been planned to evaluate the efficacy & tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith. Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm. Secondary outcomes are defined as follows: 1. Total no of Days required to achieve fecal disimpaction in each arm 2. Cumulative dose of PEG required for fecal disimpaction in each arm 3. Proportion of subjects (> 5 years age) reporting palatability issues in each arm 4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm

NCT ID: NCT06335797 Not yet recruiting - Constipation Clinical Trials

Optimization of Postoperative Bowel Habits

Start date: May 2024
Phase: N/A
Study type: Interventional

Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository.

NCT ID: NCT06334198 Recruiting - Constipation Clinical Trials

The Effect of Naldemedine on Opioid-induced Bowel Dysfunction

Start date: March 12, 2024
Phase: Phase 2
Study type: Interventional

Opioid-induced bowel dysfunction is a frequent condition during opioid therapy for chronic pain. Indeed, up to 90% of people on opioid treated patients experience constipation. Standard laxative treatment is often ineffective in opioid-induced constipation, but peripheral acting mu-receptor antagonists (PAMORAs) have the potential to block the effects of opioids in the gastrointestinal tract while preserving the central analgesic effect. In this study, we will investigated the effects of Naldemedine in preventing the development of opioid-induced bowel dysfunction and constipation during treatment with tramadol

NCT ID: NCT06319729 Not yet recruiting - Clinical trials for Constipation-predominant Irritable Bowel Syndrome

A Chinese Herbal Medicine for IBS-C

CDD2105RCT1
Start date: March 25, 2024
Phase: Phase 2
Study type: Interventional

This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up.

NCT ID: NCT06311097 Recruiting - Healthy Clinical Trials

Dairy Products to Your Gut and Brain

YourGutBrain
Start date: April 8, 2024
Phase: N/A
Study type: Interventional

The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain. In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function.

NCT ID: NCT06303245 Recruiting - Clinical trials for Cesarean Section; Complications, Wound, Dehiscence

Effects of Abdominal Binders and TENS on Puerperium Period After Cesarean Section

Start date: February 23, 2023
Phase: N/A
Study type: Interventional

To determine the combined effects of abdominal binders and TENS on post-operative pain, distress and constipation in puerperium period after cesarean section

NCT ID: NCT06303011 Completed - Constipation Clinical Trials

Abdominal Massage With TENS on Parasacral Versus Sacral Area on Symptom,Severity & QOL in Chronic Constipation Females.

Start date: March 15, 2023
Phase: N/A
Study type: Interventional

Constipation is Infrequent or difficult evacuation of FECES. These symptoms are associated with a variety of causes, including low DIETARY FIBER intake, emotional or nervous disturbances, systemic and structural disorders, drug-induced aggravation, and infections. Patients complaining of constipation may mean different things by the term The frequency of their bowel actions may be less than 'normal', their stools maybe difficult to pass, or they may have a sense of malaise or abdominal discomfort which they attribute to a 'sluggish bowel', though the stool frequency and consistency are apparently normal. Objective of this study is to compare effects of Abdominal massage. withTENSonparasacralversussacralareaonsymptomseverityandqualityoflifein severechronicconstipationamongyoungfemales.

NCT ID: NCT06298331 Not yet recruiting - Constipation Clinical Trials

Investigation of the Additional Effects of Aerobic Exercise Training to Abdominal Massage in Functional Constipation

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the additional effects of aerobic exercise to abdominal massage in patients with functional constipation. There are several studies investigating the effects of massage and aerobic exercise separately in functional constipation. However, to the best of our knowledge, there are no studies combining abdominal massage and aerobic exercise to demonstrate additional effects. By combining these two approaches, we believe that a higher and broader effect (local and systemic) and perhaps a cure for constipation (reaching the ideal defecation frequency or asymptomatic status) can be achieved. Therefore, this study will include individuals between the ages of 18-65 who have a diagnosis of functional constipation and who agree to participate in the study. This study is designed as a randomized controlled trial.