Clinical Research Directory

Adults With Constipation

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 8 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 Akk09 supplementation.

Butyrate Yogurt for Cancer Constipation

Constipation is a common yet underrecognized supportive care issue in cancer patients. Its consequences extend beyond physical discomfort to include impaired quality of life, reduced opioid adherence leading to inadequate analgesia, and increased risks of fecal impaction, emergency visits, and hospitalization. Current management strategies-including laxatives, stool softeners, prokinetics, and PAMORAs-remain suboptimal due to limited effects on gut dysbiosis, mucosal barrier dysfunction, and chronic inflammation, as well as issues related to polypharmacy, variable efficacy, and long-term tolerability. Hence, there is a clear need for novel, well-tolerated, long-term interventions with nutritional benefits that target the gut microbiota-mucosal barrier-motility axis. Short-chain fatty acids (SCFAs), particularly butyrate, are key microbial metabolites that may improve constipation through multiple mechanisms: enhancing intestinal motility via enteric nervous system regulation, reinforcing mucosal barrier integrity and mitigating low-grade inflammation, and restoring gut microbial-metabolite homeostasis. Butyrate supplementation therefore holds mechanistic promise for cancer-related constipation. The "Small Blue Can High Dietary Fiber Butyrate SCFA Yogurt" (Blueglass) is designed with a "probiotics + prebiotics + acids" synergistic fermentation platform, delivering ≥70 mg/100 g butyrate combined with high dietary fiber. Compared with conventional laxatives or single-agent butyrate, this yogurt-based formulation offers potential advantages in patient acceptability, long-term adherence, dual exogenous and endogenous SCFA support, and multi-target action on motility, microbiome, and barrier function, making it a promising candidate for supportive care in this population.

Research on the Efficacy and Mechanism of Shouhui Tongbian Capsules in Treating Postoperative Constipation of Benign Anal and Rectal Diseases Based on Gut Microbiota Analysis

The goal of this clinical trial is to evaluate whether Shouhui Tongbian Capsule can improve postoperative constipation in adults aged 18 to 75 years after surgery for benign anorectal diseases, including hemorrhoids and anal fistula. The clinical trial will also evaluate the safety of Shouhui Tongbian Capsule and explore associations between treatment effects and changes in gut microbiota, metabolic profiles, and inflammatory indicators. The main questions are: Does Shouhui Tongbian Capsule improve constipation symptoms after benign anorectal surgery? Does Shouhui Tongbian Capsule reduce postoperative and defecation-related pain? Does Shouhui Tongbian Capsule improve quality of life and anorectal function? What adverse events occur during treatment? Are clinical improvements associated with changes in gut microbiota, metabolic profiles, or inflammatory indicators? Researchers will compare Shouhui Tongbian Capsule with lactulose to evaluate differences in efficacy and safety for postoperative constipation. Participants will: Receive either Shouhui Tongbian Capsule three times daily or lactulose once daily for 14 days Complete assessments of constipation symptoms, pain, quality of life, and anorectal function Provide stool and blood samples before treatment and on Day 14 Attend assessments during treatment and approximately 1 month after surgery Report adverse events and other medical problems during participation

Radicle GI HealthTM VNB: A Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes

Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo. The study will last approximately 35 weeks.

A Study of Microbiome Transplantation for the Treatment of Constipation and/or Significant Bloating in Patients With Systemic Sclerosis

The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and/or significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.

Effect of Preoperative Abdominal Effleurage on Postoperative Constipation

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.

Validation of a Novel Functional Food Designed to Meet the Nutritional Needs of People Living With Parkinson's Disease

Constipation is a common complication and non-motor symptom of Parkinson's disease (PD) and affects up to 80% of people with PD. It is in fact within the non-motor symptoms that nutrition and dietetic intervention could have the greatest impact. Research suggests that increasing the amount of fibre in the diet could help to alleviate the effects of constipation. Inulin is a type of fibre widely found in a variety of vegetables, and recent studies have shown that inulin can improve constipation in people with PD. With the assistance of a food company, the investigators have developed a functional drink, enriched with chicory inulin and other key nutrients, including B-vitamins and vitamin D (which are suggested within the literature to be beneficial in PD). Therefore, the investigators plan to conduct a 12-week feasibility study to test the effect of this novel functional drink on gut health outcomes, nutritional status, and overall quality of life in people living with PD.

GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity

Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.

Test Anxiety on Bowel Health and Constipation in Students

This observational cross-sectional study aims to examine the relationship between test anxiety, bowel health, and constipation in university students. The study will include undergraduate students aged 18 years and older who are studying in the Physiotherapy and Rehabilitation Department at Lokman Hekim University and who are in their final examination period. Participants will complete self-report questionnaires during a single face-to-face assessment session. Constipation status will be evaluated using the Rome IV criteria, stool form will be assessed using the Bristol Stool Scale, constipation severity will be assessed using the Constipation Severity Instrument, and test anxiety level will be assessed using the Test Anxiety Inventory. Sociodemographic characteristics and bowel-related symptoms will also be recorded. The study does not include any intervention or treatment. The findings are expected to help better understand whether test anxiety during examination periods is associated with bowel health problems and constipation in university students.

Development of a Constipation Risk Assessment Scale for Hospitalized Patients.

Develop a risk assessment scale for constipation of hospitalized patients to identify at an early stage high-risk individuals and to implement the appropriate means of prevention.

Indiana University Gastrointestinal Motility Diagnosis Registry

Develop a registry (list of patients) with accurate clinical motility diagnosis. This registry will help the doctors to identify the patients with specific disease conditions. It will also help in promoting future research in gastroenterology motility disorders

Enabling Microbiomics- Driven Personalized Nutrition

The goal of this observational research study is to determine how diet contributes to various gastrointestinal related conditions. The main question investigators aim to answer is: Are host genetics, diet, and microbiome all important determinants of GI disorders, and how their relative contribution varies among individuals and populations.

Probiotic Improve Constipation

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.

MOWOOT Device Treatment for Adults With Chronic Constipation

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.

Dairy Products to Your Gut and Brain

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.

Radicle GI Health RDH™: A Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

A Study of Herbal Supplements in Cancer Survivors With Constipation

The purpose of this study is to find out whether MZRW is an effective treatment for constipation in cancer survivors. The researchers will compare MZRW with placebo, a pill that looks like MZRW and is given in the same way, but contains no medication. The researchers will also study the effect MZRW has on the gut microbiome. The gut microbiome is a diverse community of microorganisms living in the digestive system, essential for digestion and immune function.

Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

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.

Effectiveness of Electromagnetic Field Therapy in Chronic Constipation

This study was a prospective randomise controlled study. The aim of this study was to determine the effect of transabdominal magnetic field therapy on constipation severity in patients with chronic functional constipation. After eligibility assessment and baseline measurements, participants were randomly allocated into three groups: the transabdominal magnetic field therapy group, the sham group, and the standard care group. All groups received Constipation Management Education. The education program, developed based on the literature, covered the definition, causes, risk factors, medication use, and lifestyle-related factors associated with constipation. In addition, behavioral recommendations were provided, including maintaining regular bowel habits, adopting an appropriate defecation posture, avoiding delayed defecation and excessive straining, and optimizing diet, fluid intake, and physical activity. The MFT group received active transabdominal magnetic field therapy twice weekly for 8 weeks. The sham group underwent the same device placement and session protocol; however, the device was used without delivering an active magnetic field. The standard care group received only Constipation Management Education. Participants were followed face to face for 8 weeks, and individual counseling was provided when needed to answer their questions. The primary outcome measure was the Constipation Severity Instrument (CSI). Secondary outcomes were the CSI subscales, the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL), the Bristol Stool Form Scale, complete spontaneous bowel movements (CSBM), and defecation time.

The Effect of Preoperative Abdominal Massage on Postoperative Constipation

The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are: • Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent constipation? To see if abdominal massage is effective in preventing constipation, researchers will not apply any treatment to the second group and will compare the two groups. Participants will: * Provide researchers with information about their preoperative and postoperative stool consistency and constipation status. * Inform the researchers if the group that received the massage experiences any adverse effects from the massage.

Treatment of Fecal Incontinence and Chronic Constipation With Low-volume Irrigation

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).

A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

This research is studying how the availability of a Food and Drug Administration (FDA)-cleared point-of-care, bedside device bedside device called Rectal Expulsion Device (RED) can be used to evaluate constipation in the participants' routine office visit with the participants' care provider. In this research, participants will be asked to complete a survey prior to the gastroenterology office consultation. Health-related information will be collected for this research study. There are no additional study visits for this research study.

Guideline to Implementation: A Rapid Clinical Care Pathway to Care for Patients Affected by Chronic Constipation

The study is being completed to test the pilot implementation of a rapid clinical care pathway for chronic constipation in the University of Michigan Gastroenterology clinic. This study will learn how often patients get better and how satisfied patients are with care decisions, when seen by a gastroenterologist for medical advice on constipation.