Clinical Research Directory

Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State

Study Title: Randomized Controlled Clinical Study on Acupuncture Combined with Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome with Anxiety State. This single-center, randomized, single-blinded sham-controlled trial enrolls adults aged 18-70 with constipation-predominant irritable bowel syndrome (IBS-C) and anxiety. All participants receive standardized weekly acupuncture for 4 weeks. Participants are randomly assigned 1:1 to either real daily home Transcutaneous Electrical Acupoint Stimulation(TEAS)at Zusanli acupoint or sham non-acupoint TEAS. The total study period lasts approximately 10 weeks, including 2-week screening, 4-week intervention and 4-week post-treatment follow-up. The primary outcome is weekly complete spontaneous bowel movements (CSBM) at week 4. Secondary outcomes cover anxiety, sleep quality, abdominal symptoms, quality of life and safety. Researchers will test whether adding real home-based TEAS to acupuncture improves bowel and emotional symptoms, and evaluate treatment safety and tolerability.

Co-Development and Validation of Colonic Symptom Pictograms for Young People

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.

The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation

The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life. The primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.