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Showing 1-20 of 23 trials
NCT04666155
The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.
NCT07202481
The goal of this clinical trial is to evaluate the effect of dietary fibers in the treatment of functional constipation in women. It will also assess the potential side effects associated with fiber consumption. The main questions it aims to answer are: * In women with constipation who do not consume adequate dietary fiber, does supplementation help improve bowel function? * Among the fibers studied, is there any hierarchy of effect in the treatment of constipation (i.e., is one more effective than the other)? The researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact. Participants will: * Consume 20 g of fiber daily for 6 days, divided into two doses of 10 g each. * Attend a nuclear medicine visit at the end of each 6-day fiber period to perform scintigraphy. * Keep a daily record of bowel habits and dietary intake.
NCT07483229
This study aims to compare the effectiveness of two different acupuncture techniques for treating a specific type of chronic constipation, known in Traditional Chinese Medicine as "Yang deficiency type" chronic functional constipation. Chronic functional constipation is a common condition characterized by difficult or infrequent bowel movements. The "Yang deficiency" pattern is believed to be caused by a lack of functional energy (Qi) and warmth in the body, leading to sluggish bowel motility. This study will enroll 60 eligible participants who will be randomly assigned to one of two groups: Experimental Group: Participants will receive "warm needling" therapy. This involves inserting acupuncture needles at specific points (Tianshu and Guanyuan) and then burning a small moxa stick on the needle handle to generate heat. Control Group: Participants will receive electroacupuncture at the same acupoints. This involves attaching the needles to a device that delivers a mild electric current. Both groups will receive treatment every other day, three times a week, for a total of four weeks. We will assess their constipation symptoms, anxiety and depression levels, and quality of life using standardized questionnaires immediately after the 4-week treatment and again 6 months later. The goal is to see which method provides better relief, both in the short term and long term.
NCT07427914
The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use. The main questions this study aims to answer are: Does Benemix® help improve bowel movement frequency and consistency in adults with constipation? What medical problems, if any, do participants experience while taking Benemix®? Adults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests. Participants will also receive follow-up phone calls to record: * daily treatment adherence * signs and symptoms * the number of bowel movements each day.
NCT07337343
Severe constipation affects 10% of children, often leading to significant physical and emotional distress. While constipation is commonly associated with impaired bowel movements, it is fundamentally linked to abnormalities in colonic motility - the coordinated contractions that facilitate passage of stool through the colon and out of the body. Diagnosis of constipation is based upon the Rome IV criteria, which assess symptoms as reported or remembered over the previous 3 months. However, reporting symptoms experienced can be challenging for children and young people for many reasons, such as the overlap of sensations, including fullness, bloating, and discomfort, and an inability to recall or precisely distinguish and describe what they are feeling. This study intends to design, develop, and validate symptom pictograms for children aged 8-17 with colonic or lower gut symptoms.
NCT04306939
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.
NCT07121062
It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas. To address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething. This study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues. Parents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided. By validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.
NCT07065942
Constipation is the most common gastrointestinal manifestation in diabetic patients. Emerging evidence suggests that gut microbiota dysbiosis may contribute to the pathogenesis of diabetes, highlighting the need to investigate its role in diabetic constipation, though current research remains limited. Current management of diabetic constipation primarily relies on bulk-forming and osmotic laxatives. Additionally, microbiome-modulating agents (e.g., probiotics, prebiotics, and synbiotics) may serve as adjunctive therapies by regulating gut microbiota and enhancing intestinal motility. Lactulose, a well-tolerated osmotic laxative with prebiotic effects, is widely recommended in clinical guidelines. It promotes short-chain fatty acid production, increases fecal volume, and accelerates colonic transit, thereby alleviating constipation. However, its specific impact on gut microbiota composition and metabolic pathways in diabetic constipation remains unclear. This study aims to explore changes in fecal microbiota and metabolomic profiles in diabetic patients with chronic constipation following treatment with lactulose alone or in combination with Bacillus subtilis-Enterococcus faecium probiotics, providing mechanistic insights into prebiotic therapy for this condition.
NCT05496543
Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".
NCT06836024
The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation. The main questions it aims to answer are: 1. Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC? 2. What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period? Researchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC. Participants will: Undergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups: 1. Actazin chewable tablets (titrate to effect: 600-2400 mg/day) + placebo PEG 3350 2. PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events. Additionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes. Outcomes: Primary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate. Secondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability. This study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).
NCT04082689
The overall purpose is to assess whether assisted infant toilet training during the first year of life can prevent functional gastrointestinal and urinary tract disorders up to 4 year of age. Healthy Swedish children will be randomized to start assisted infant toilet training at 0-2 months of age or at 10-11 months of age. The toilet training process will be described including mother-to-infant attachment and parental stress.
NCT05823259
The primary aim of this study will be to determine if a respiratory muscle training program that includes both inspiratory muscle training (IMT) and expiratory muscle training (EMT), targeted at improving respiratory muscle performance-based measures combined with patient education about breathing on the toilet will improve patient satisfaction scores in individuals with chronic constipation (CC).
NCT04587635
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
NCT05714410
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults With Constipation as Compared to Placebo (Typhoon 2)
NCT06570668
This is a single-center, randomized, double-blind, placebo-controlled, single-dose study to confirm the safety, tolerability and pharmacokinetic profile of CDD-2101 in healthy subjects. A total of 20 subjects aged 18-65 years with a Body Mass Index (BMI) of 18.5-29.9 kg/m2 will be hospitalized and randomized in a 1:1:1:1:1 ratio (N=4/group) to receive one dose of CDD-2101 at 5, 10, 15 or 20 g and/or placebo by taking a suspension in water orally. Subjects will complete a daily bowel habit diary 7 days and refrain from food containing any of the botanicals in CDD-2101 for at least 3 days prior to randomization. Subjects will also need to abstain from the consumption of any xanthine containing products (e.g. coffee, tea, chocolate, or Coca-Cola like drinks) more than 6 cups per day (or equivalent) 24 hours before randomization. A 12-lead electrocardiogram (ECG) and a full physical examination will be performed at pre-dose and 24 h post-dose. Blood samples will be collected at 0 (pre-dose), 0.25, 0.5, 1, 2, 4, 8, 12 and 24 h post-dose. Urine samples will be collected immediately before and at 0-3 h, 3-6 h, 6-9 h, 9-12 h and 12-24 h post-dose. Vital signs will be measured at 0 (pre-dose), 1, 2, 3, 4, 8, 12 and 24 h post-dose. Adverse events (AEs) will be monitored during the study period. After the 24 h post-dose procedures are completed, the investigator will confirm the subjects are in good health before discharging them. All subjects will have a follow-up visit 3 days after the dose of investigational drug. Plasma samples will be analyzed for complete blood count, liver and kidney function markers, total cholesterol, glucose, calcium and marker compounds of CDD-2101. Urine samples will be processed for quantitation of marker compounds of CDD-2101. The primary endpoint will be safety and tolerability of CDD-2101, with vital signs, reported number and seriousness of AEs, physical examination, and laboratory tests as outcome measures. The secondary endpoints will be the pharmacokinetic profile, with outcome measures including peak plasma concentration (Cmax), time to reach Cmax (Tmax), area under the curve (AUC) from 0 to 24 h post-dose and renal excretion of marker compounds, and bowel movement with the number of complete spontaneous bowel movement (CSBM) and stool quality based on the Bristol Stool Form Scale as outcome measures.
NCT03078634
Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.
NCT06122558
This project aims to study the benefits of probiotic in modulating gut microbiota and treating functional constipation in patients aged 18-81.
NCT05447481
Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. Adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in this study.
NCT04086134
This study is a randomised, parallel group, controlled trial, comparing the effects of fruit products as to their physiological, microbiologic and metabolomic effects on the gut, as well as their effects on the dietary intake and quality in healthy people with constipation.
NCT02138136
This study is for children with constipation. Children who completed 3 months of treatment in the earlier study (NCT02042183): * were invited to participate * will receive lubiprostone for 9 more months * will see if lubiprostone safely relieves their constipation if taken for a whole year