Constipation

Researchers are evaluating how abdominal massage affects gastrointestinal functions in patients who are mechanically ventilated and receiving enteral nutrition in intensive care units. This study aims to assess abdominal massage's impact on bowel movement frequency, gastric residual volume, and abdominal distension. The trial is designed as a prospective, single-blind randomized controlled trial to provide scientific evidence for abdominal massage use in this patient group. Participants are randomly assigned to either an intervention group receiving abdominal massage or a control group receiving standard care without massage. Abdominal massage is performed twice daily for 15 minutes over three days using specific techniques like effleurage, petrissage, and vibration. The massage is given at the bedside in a semi-Fowler position before enteral feeding, with routine nursing care provided to all patients. Throughout the study, researchers monitor bowel movements, gastric residual volume, abdominal distension, and stool consistency using specialized forms and scales twice daily. Data collection includes clinical assessments such as Glasgow Coma Scale and APACHE II scoring. The study lasts three days for each patient, with detailed recording of gastrointestinal function parameters to evaluate the effects of abdominal massage compared to standard care.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

This observational study aims to evaluate the effectiveness of Danning Tablets in relieving dyspepsia symptoms in patients who experience digestive issues such as upper abdominal pain, bloating, loss of appetite, acid reflux, or constipation. It seeks to understand how factors like symptom severity, patient demographics, dosage, and treatment duration influence the tablets' impact. The study is sponsored by Shanghai Hutchison Pharmaceuticals Limited and focuses on patients already using Danning Tablets in their regular care. Participants in this study are adults aged 18 to 75 who are currently taking Danning Tablets for indigestion symptoms as part of their regular treatment. The study involves collecting questionnaire responses at two and four weeks after starting their treatment to assess changes in symptoms and quality of life. There is no control group since this is an observational study of patients already taking the medication. Throughout the study, participants will complete assessments measuring the rate of symptom improvement, including dyspepsia symptom relief, gastrointestinal symptom rating scales, abdominal pain ratings, and quality of life using the EQ-5D-5L questionnaire. Adverse events are also monitored during the two- and four-week periods. The main outcome is the responder rate for dyspepsia symptoms at four weeks after enrollment, with all participation lasting up to four weeks.

This research aims to observe the effectiveness and safety of the traditional Chinese medicine formula SCD-2101 in treating functional constipation in elderly individuals aged 60 years and above who meet the Rome IV criteria for this condition. The trial is a single-arm, open-label pilot study involving 14 participants who have limited bowel movements and are capable of understanding Chinese and using electronic diaries. Participants will take 150 milliliters of SCD-2101, a herbal medicine containing four herbs, twice daily after meals for two weeks. This is followed by a two-week follow-up period without treatment to monitor ongoing effects. All participants receive this same intervention without a comparison group. Throughout the study, participants will record their bowel movements using an electronic diary to measure the primary outcome of complete spontaneous bowel movements (CSBM) response rate at the end of treatment. Secondary outcomes include changes in CSBM and spontaneous bowel movements (SBM) per week and monitoring of any adverse reactions. Safety assessments include physical examinations and tracking any side effects during the trial and follow-up periods, with data analyzed using SPSS software.

Researchers are evaluating the impact of regular use of a consumer-grade FODMAP-targeting digestive enzyme blend called FODZYME® on gastrointestinal symptoms in adults who experience self-reported bloating. The study focuses on how this enzyme blend affects symptoms such as bloating and abdominal pain, which are often triggered by fermentable carbohydrates known as FODMAPs. This is a randomized, double-blind, placebo-controlled crossover trial that aims to provide a more flexible alternative to the restrictive Low FODMAP Diet by breaking down FODMAPs before they ferment in the colon. Participants will take the enzyme blend or a placebo with each meal, snack, or substantial beverage, applying it directly to their food. The trial is divided into two main periods: half the participants will start with the enzyme blend for four weeks followed by a two-week washout and then switch to placebo for another four weeks; the other half start with placebo and then switch to the enzyme blend after the washout. The study product is designed to target specific FODMAPs like fructan, GOS, and lactose and is intended for adults with or without IBS symptoms. During the study, participants will complete daily questionnaires and assessments over about 19 weeks, including patient-reported outcome measures for bloating, gastrointestinal symptoms, abdominal pain, food-related quality of life, and anxiety. The study is conducted remotely, allowing participants to complete assessments at home using a smartphone app. Safety is monitored by excluding those with known allergies to corn or previous reactions to digestive enzyme supplements, and researchers will review changes in bloating symptoms as the primary outcome.

Researchers are evaluating the safety, side effects, and effectiveness of brenipatide (LY3537031) in adults with Irritable Bowel Syndrome-Constipation (IBS-C). This study compares brenipatide given as a subcutaneous injection with a placebo to better understand how well the drug is tolerated and its impact on IBS-C symptoms. The trial is a phase 2, randomized, double-blind, placebo-controlled study sponsored by Eli Lilly and Company. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study is expected to last about 35 weeks. Researchers will monitor participants closely to assess their response to the treatment during this period. Throughout the study, participants will be asked to record symptoms such as abdominal pain and bowel movements using a daily electronic diary. The main outcome measured is the percentage of participants showing a weekly clinical response over weeks 9 to 16. Secondary outcomes include weekly abdominal pain and complete spontaneous bowel movement responses during the same timeframe. Safety and side effects will also be carefully monitored during the study period.

Researchers are evaluating the herbal formula Ma-Zi-Ren-Wan (MZRW) as a treatment for constipation in cancer survivors. This study aims to compare MZRW with a placebo to see if it improves bowel movements and to study its effect on the gut microbiome, which is important for digestion and immune health. The trial is a double-blinded, randomized controlled study led by Memorial Sloan Kettering Cancer Center. Participants will receive either MZRW or a placebo pill for 2 weeks. MZRW contains extracts from several herbs, including hemp seed, fresh rhubarb, white peony, aurantium immaturus, magnolia bark, and apricot kernel. After the 2-week treatment period, participants will be followed for an additional 2 weeks. The study compares the number of spontaneous bowel movements from the start to the end of the 2-week treatment. During the study, participants will complete assessments related to their bowel movements and symptoms of constipation. Researchers will monitor changes in spontaneous bowel movements as the main outcome. The study includes a baseline period, a 2-week treatment phase, and a 2-week follow-up. Participants will provide informed consent and complete all study assessments independently in English. The total participation lasts around 4 weeks, including treatment and follow-up.

Researchers are studying how the intestinal bacteria in people with systemic sclerosis-related constipation and/or significant bloating may change after receiving microbiome transplantation. This Phase 2 study aims to understand the safety and tolerability of two types of microbiome transplant products (frozen and lyophilized PRIM-DJ2727) and how these treatments affect gut bacteria diversity and patient symptoms. Participants will be randomly assigned to receive either the microbiome transplant or a placebo. The transplant is given both as capsules taken twice weekly from week 2 through week 10, and as a retention enema at the start and during week 11. The placebo group receives matching capsules and enemas on the same schedule. This design helps compare effects between the active treatment and placebo. During the study, participants will have their symptoms assessed using several questionnaires and stool diaries before treatment and at week 12. Researchers will also monitor gut transit times, inflammatory markers, and changes in gut bacteria. The study includes follow-up visits to evaluate safety and outcomes over 12 weeks. The goal is to track improvements in constipation and bloating and understand changes in gut microbiome composition.

Researchers are studying prucalopride, a medicine used to treat chronic idiopathic constipation (CIC), in breastfeeding women. The study aims to measure how much prucalopride passes into breast milk and to monitor the growth, development, and possible side effects in the babies who are breastfed by mothers taking this medication. Participants must be women treated with prucalopride for functional constipation and breastfeeding their infants. Participants will provide one set of breast milk samples collected over 24 hours using an electric breast pump at home. These samples will be sent to the laboratory for analysis. The study observes participants who have been prescribed prucalopride tablets under medical supervision before joining and who continue breastfeeding during sample collection. During the baby's first year, researchers will conduct telephone interviews every two months to ask questions about the baby and will ask participants to complete questionnaires assessing their infant's growth and neurodevelopment. The study will measure prucalopride levels in milk at various times after dosing and track infant growth changes, developmental milestones, and any reported adverse effects up to one year of age.

Researchers are studying adults with irritable bowel syndrome with constipation (IBS-C) to see if combining a standard medication called linaclotide with immersive virtual reality (VR) therapy improves overall IBS symptoms and quality of life compared to linaclotide with sham VR. The study focuses on patients who meet Rome IV criteria for IBS-C and aims to measure changes in symptoms like abdominal pain, constipation, bloating, psychological distress, and work productivity. Participants are randomly assigned to one of two groups: one receiving linaclotide 290 mcg plus active immersive VR content using an Oculus Quest 2 device, and the other receiving linaclotide plus sham VR content on the same device. The study treatment lasts for 8 weeks, during which patients use the VR therapy alongside their medication. During the study, participants will be assessed for changes in IBS symptoms, quality of life, abdominal pain, bloating, psychological distress, and work productivity using validated questionnaires and rating scales. These measurements are taken at baseline and again at the end of 8 weeks. The trial is double-blinded and randomized to ensure unbiased results. The total participation period covers the 8-week treatment and evaluation timeframe.