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Showing 1-20 of 316 trials
NCT07536698
Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with functional constipation who are receiving macrogol and are candidates for weaning. Participants aged 2 to 6 years will be randomized to receive either the active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. The study will assess persistence of constipation after macrogol discontinuation, as well as stool consistency, distress during evacuation, soiling episodes, and treatment compliance.
NCT07529457
This randomized, double-blind, placebo-controlled trial will assess the clinical effects of Akk09 in adults with functional constipation. Participants will receive Akk09 or placebo for 4 weeks. The study will evaluate changes in bowel habits and symptom burden, as well as alterations in host inflammatory status, immune modulation, microbial ecosystem dynamics, neuroendocrine signaling related to the gut-brain axis, and systemic metabolic responses, to characterize the overall physiological impact of BC09 supplementation.
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.
NCT07507955
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 4 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.
NCT07215351
The purpose of the present study is to investigate the impact of a natural dietary supplement, Inno Cleanse™, to reduce bloating in a population of otherwise healthy men and women, who claim to feel frequently bloated. Inno CleanseTM dietary supplement is manufactured in the United States under current Good Manufacturing Practices (cGMP) and is marketed by InnoSupps as a digestive health aid. It is sold in the United States on the company's website, Amazon, and in many large retail outlets. It remains a very popular product, with close to 1.4 million units sold since 2020, with a reported 66,000 units sold in the past three months. Despite the prevalence of dietary supplements identifying as digestive aids, detoxification, and cleanses, very little research has been done to determine their effectiveness. The product appears to be well-designed, with multiple ingredients included which have scientific evidence of effectiveness. That said, and despite the overall positive reviews, there is no known clinical research to support the product's effectiveness. Therefore, the aim of this study is to evaluate the efficacy of the Inno Cleanse product to reduce bloating and result in other positive outcomes (weight loss). This study will be run as a double-blind placebo-controlled trial, in which subjects will use the product or placebo for two weeks. It is hypothesized that treatment with the dietary supplement Inno Cleanse will result in reduced bloating, as evidenced by self-reported reductions in bloating and hunger, as well as moderate weight loss and a reduction in body circumference measures due to the reduced bloating. In addition, multiple anecdotal reports of improved skin health have been noted in those using the product. Additionally, routine blood and urine sample analysis will be performed as a secondary outcome, as a safety measure.
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.
NCT07466914
Constipation is a common problem in children with cerebral palsy and may negatively affect daily activities, quality of life, and family well-being. Several factors such as nutrition, physical activity level, functional status, and psychological condition of the caregiver may be associated with constipation in this population. The aim of this study is to investigate the presence and severity of constipation in children with cerebral palsy and to examine the factors that may be related to constipation, including dietary intake, fluid consumption, physical activity level, functional status, and caregiver psychological status. This study is an observational cross-sectional study including children with cerebral palsy aged 4-18 years and their caregivers. Data will be collected using questionnaires, clinical classification systems, bowel diaries, nutrition records, and psychological scales. No intervention will be applied to participants.
NCT07470892
This is a prospective, multicenter, real-world observational study to evaluate the impact of perioperative parenteral nutrition (PN) with fish oil-containing lipid emulsion on outcomes in adult patients with constipation undergoing elective colon surgery. The study will compare two clinical nutrition strategies: (1) PN with fish oil-containing lipid emulsion started before surgery and continued after surgery, and (2) PN with fish oil-containing lipid emulsion started only after surgery. Eligible participants are adults (18-75 years) with slow-transit constipation (STC) or megacolon who are scheduled for elective colon surgery and have nutritional risk (NRS2002 score \>=3). The primary objective is to compare the incidence of postoperative complications between these two PN timing strategies. Secondary objectives include comparison of perioperative nutritional status, postoperative inflammatory status, prognosis, and safety outcomes. This study will collect and analyze clinical data, laboratory indicators, perioperative recovery outcomes, follow-up assessments, and safety information in routine clinical practice. Outcomes include postoperative complication rates, changes in nutritional and inflammatory markers, bowel function recovery, length of hospital stay, constipation-related symptoms, quality of life, and adverse events. No experimental intervention will be assigned as part of this observational study. The planned sample size is 306 participants. The findings may help optimize perioperative nutritional support strategies for patients with constipation undergoing surgery.
NCT07462481
To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.
NCT06528470
The overall objective of this study is to determine the effect of posterior tibial nerve stimulation (PTNS) on children with constipation due to pelvic floor dyssynergia. Our main hypothesis is that PTNS effectively treats children with constipation secondary to pelvic floor dyssynergia through modulation of anorectal function. We will perform a single-center, randomized controlled pilot study comparing PTNS to sham stimulation in children with constipation secondary to pelvic floor dyssynergia.
NCT07444008
This is a randomized, single-blind, placebo-controlled study to evaluate the efficacy of the dietary supplement BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) in managing functional gastrointestinal disorders and cutaneous symptoms of food allergy in infants during the first months of life. The aim of the study is to assess clinical effects of BioAmicus Complete drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life. A prospective study comparing two treatment groups: Group 1 (treatment group) - 70 infants. Group 2 (control group) - 70 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fenhel)), etc.
NCT06335797
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.
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.
NCT05773742
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).
NCT07410286
Hirschsprung's disease is characterized by a lack of enteric nervous system ganglion cells (aganglionosis) in a variable extent of distal bowel. It is the commonest congenital bowel motility disorder and affected neonates usually present with distal intestinal obstruction in the first few days of life. Despite the common underlying pathology of Hirschsprung disease, it has varying presentations. Infants classically present with delayed passage of meconium, feeding intolerance, and bilious emesis. In fact, 90% of children with Hirschsprung will not have passage of stool within the first 24 h of life. Neonates and infants can also present with abdominal distension, failure to thrive, enterocolitis, or bowel perforation. Hirschsprung's disease is characterized by a variable length of distal colonic aganglionosis. In approximately 80% of cases, it is short-segment, and only involves the rectosigmoid colon. Less commonly, it can extend proximal to the sigmoid colon (15%), include the entire colon (total colonic aganglionosis, 5%), or rarely, the entire intestine (total intestinal aganglionosis). The principles of the operation are to remove the aganglionic colon and connect the normally innervated bowel just above the anus, at a level which prevents further functional obstruction, but at the same time preserves fecal continence. The surgical treatment of Hirschsprung's disease has evolved from the historical three-stage procedure to a single-stage technique. Since then, multiple series reported its safety, efficacy, and feasibility in the management of HSCR in the neonatal period. Swenson and Bill, Soave, and Duhamel are the most common procedures for Hirschsprung's disease. However, there is a heated debate about which technique gives the best short- and long-term outcomes. There are many surgical approaches to Hirschsprung's disease, including the transabdominal approach (TAB) and transanal endorectal pull-through (TERPT). The TAB includes 4 types: the Swenson, Duhamel, Rehbein, and Soave procedures. Both the Swenson and the Soave procedures have been adapted as transanal approaches. Transanal access is based on the traditional surgical techniques performed previously in abdominal approach. This type of surgery is used for the treatment of small children. Transanal endorectal pull-through method performed with transanal access is characterized by low invasiveness of surgery and good results of treatment. The Swenson procedure involves the removal of the entire affected site and end-to-end anastomosis of the normal colonic anal canal. In the Soave procedure, physiological saline is injected into the rectum after cutting through the rectal muscle layer in a circular manner, while keeping the mucosa intact to the dentate line level.
NCT07099222
The goal of this clinical study is to improve upon the standard practice of utilizing nerve blocks to enhance the satisfaction of patients undergoing shoulder, or foot and ankle surgery regarding their quality of pain control, the duration of their nerve blocks, as well as the avoidance of opioid medications and subsequently their undesirable side effects. The researchers hypothesize that dexmedetomidine and dexamethasone (Dex-Dex) will work synergistically as adjuncts in a low, non-weight based formula. This would allow the investigators to improve patient satisfaction by providing them with a superior means of pain control that is longer in duration with a decreased probability of unwanted side effects. The proposed clinical study will be a prospective, randomized control trial.
NCT07344532
This randomized controlled study aims to evaluate the effect of preoperative abdominal superficial effleurage training on the development of postoperative constipation in patients undergoing abdominal surgery. Participants will be randomly assigned to an intervention group receiving abdominal superficial effleurage training in addition to routine care or to a control group receiving routine care only. The effleurage technique will be taught preoperatively and performed by patients postoperatively. Postoperative constipation will be assessed on the 10th postoperative day using the Bristol Stool Form Scale. The findings of this study are expected to contribute to non-pharmacological nursing interventions for the prevention of postoperative constipation.
NCT07352449
Constipation is defined as having bowel movements fewer than three times per week or experiencing subjective complaints such as a sensation of incomplete evacuation, abdominal bloating, tightness, restlessness, or discomfort despite normal bowel frequency, while chronic constipation is not a disease but a symptom characterized by decreased defecation frequency, hard stools, straining, and a persistent feeling of incomplete evacuation, with its definition varying among individuals. The aim of the present study is to investigate the acute effects of a single session of classical abdominal massage on arterial stiffness, muscle oxygenation, exercise capacity, quality of life, and sleep quality in individuals with chronic constipation. At least 30 participants diagnosed with chronic constipation will be included and randomly allocated into an intervention group or a placebo group. In both groups, arterial stiffness, muscle oxygenation, exercise capacity, constipation-related quality of life, and sleep quality will be assessed. In the intervention group, all assessments will be conducted immediately before and after the massage session, whereas in the placebo group, assessments will be performed before and after a waiting period equivalent to the duration of the massage. Normality of the variables will be examined using the Shapiro-Wilk test, histograms, and detrended plots. For between-group comparisons at baseline, independent samples t-tests will be used for normally distributed variables and Mann-Whitney U tests for non-normally distributed variables, while categorical data will be compared using chi-square tests. Post-hoc comparisons will be conducted using Bonferroni-adjusted procedures, and the level of statistical significance will be set at p \< 0.05.
NCT07344402
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) works to treat refractory constipation in adults. It will also learn about the safety and tolerability of taVNS. The main questions it aims to answer are: Does taVNS improve constipation symptoms, as measured by the change in complete spontaneous bowel movements per week (ΔCSBMs/week) from baseline to post-treatment? What medical problems or side effects do participants have when receiving taVNS? Does taVNS reduce the need for rescue laxatives? Researchers will compare active taVNS to sham taVNS to see if taVNS works to treat refractory constipation. Participants will: Be randomly assigned (double-blind) to receive active taVNS or sham taVNS for 20 days Receive stimulation twice daily, 30 minutes per session, with a 12-hour interval between sessions Receive stimulation at 30 Hz with 200 μs pulse width, delivered to the left cymba conchae Keep a daily diary of bowel habits and symptoms, including CSBMs, and rescue laxative use (bowel movements occurring within 24 hours after rescue laxative use will not be counted as CSBMs)