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 massages 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 how well brenipatide LY3537031 is tolerated, its side effects, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Constipation IBS-C. This Phase 2 study compares brenipatide given under the skin with a placebo to better understand its impact on IBS-C symptoms. The trial is sponsored by Eli Lilly and Company and lasts about 35 weeks. Participants will receive either brenipatide or a placebo, both administered subcutaneously. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment effects will be measured primarily between weeks 9 and 16, focusing on the weekly composite clinical response. Secondary outcomes include abdominal pain and bowel movement responses during the same period. During the study, participants will be monitored for safety and symptom changes. They will record abdominal pain scores daily and bowel habits using a stool form scale. Researchers will review these data along with other health assessments to evaluate the study drugs effects. The total participation duration is approximately 35 weeks, including screening, treatment, and follow-up periods.

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 adults with systemic sclerosis who experience constipation andor significant bloating. The study aims to characterize the gut microbiome in these patients and evaluate the safety and potential improvements in microbiome diversity and symptoms after receiving microbiome transplantation. This phase 2 trial focuses on understanding how frozen or lyophilized microbiome transplant products affect these digestive issues in systemic sclerosis. Participants will be randomly assigned to receive either the PRIM-DJ2727 microbiome transplant or a placebo. Treatment includes taking capsules twice weekly from week 2 through week 10 and receiving a retention enema at baseline and week 11. The study uses a quadruple masking design to compare the effects of the microbiome transplant versus placebo on digestive symptoms and microbiome changes. During the study, participants will complete questionnaires assessing constipation and bloating symptoms before treatment and at weeks 11 to 12. Researchers will also monitor gut transit times with Sitz markers and X-rays, analyze microbiome diversity and metabolome changes, and track inflammatory markers and short-chain fatty acids in stool samples. Safety and tolerability are closely observed throughout the 12-week study period, which includes follow-up assessments after treatment.

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 babys 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 infants 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 evaluating whether adults with irritable bowel syndrome with constipation IBS-C experience better symptom relief and quality of life improvements when treated with a combination of linaclotide, a standard medication, and immersive virtual reality VR therapy compared to linaclotide combined with sham VR therapy. The study focuses on adults aged 18 to 70 who meet Rome IV criteria for IBS-C, aiming to assess effects on abdominal pain, constipation, bloating, psychological distress, and work productivity. Participants will be randomly assigned to one of two groups. Both groups will receive linaclotide 290 mcg as standard care. One group will use an Oculus Quest 2 VR headset with active immersive content designed to target IBS symptoms, while the other group will use the same device but only access sham VR content. The study is conducted in parallel groups with double blinding to compare the benefits of the active VR combined with linaclotide against the sham VR plus linaclotide. During the 8-week study period, participants will be monitored for changes in IBS symptoms, quality of life, abdominal pain, bloating, psychological distress, and work productivity using validated questionnaires and rating scales. Researchers will collect data at baseline and at the end of week 8 to evaluate treatment effects. The Mayo Clinic sponsors the study, which emphasizes careful monitoring and assessment to understand the combined impact of VR therapy and linaclotide on IBS-C.