Active clinical trials for "Irritable Bowel Syndrome"

This study aim to manufacture bread and pasta with an reduced content of gluten and to assess the impact of reducing the daily intake of gluten by 50% in irritable bowel syndrome (IBS) patients. Fungal proteases and selected sourdough lactic acid bacteria will be used for making wheat bread and pasta with a reduced content of gluten (RG) (-50% of traditional products). From a technological point of view, the chemical, structural and sensory features of the RG products approached those of the bread and pasta made with normal level of gluten. The efficacy and safety of new products will be compared to traditional bread and pasta by using a double blind randomized, crossover-controlled trial in IBS patients with persistent gastrointestinal symptoms. Patients will follow two weeks of a GFD diet containing RG bread and pasta and two weeks of GFD diet containing Normal Gluten bread and pasta Symptoms severity will be assessed by Irritable Bowel Syndrome Severity Score (IBS-SS), Visual Analogue Scale (VAS), Hospital Anxiety and Depression Scale (HADS) and Irritable Bowel Syndrome Quality of Life (IBS-QoL).

This study is being conducted to evaluate in participants with diarrhea-predominant Irritable Bowel Syndrome (IBS-D) the abdominal pain response to BOS-589 after 4 weeks of treatment and to evaluate the overall safety and tolerability of BOS-589 in the treatment of IBS-D during 4 weeks of treatment, relative to placebo (PBO).

The current study is designed to assess the safety, tolerability, pharmacokinetics (PK), gastrointestinal (GI) transit time and pharmacodynamic (PD) biomarkers of repeat oral doses of GSK3179106 administered for 14 days in normal healthy subjects. It is a randomized, double-blind, placebo-controlled, ascending cohort study. A total of 48 subjects will be randomized (8 subjects/cohort) with 3:1 allocation to GSK3179106 or matching placebo.

To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.

Abstract Background & Aims: Abdominal N line tenderness for diagnosis and shigyakusan for treatment of irritable bowel syndrome ( IBS ) and medically unexplained physical symptoms ( MUPS ) were studied. K1 is point of one quarters of distance from center of navel to right anterior superior iliac spine. K2 is one quarters of distance from center of navel to upside of the symphysis pubis. K3 is center of line from xiphoid process to navel. There are three relevant lines; K1-K3 line, K2-K3 line, and line of identical length to K1-K3 line originating from K2 and running parallel to K1-K3 line. Author collectively named these 'N line'. There was not the study under author's investigation that effects of shigyakusan and other medicines were compared. Author confirmed existence of mild IBS, for whose patients existing largely, various expensive examinations are spent. Method: The author put pressure on N line by deep palpitation and judged of abdominal N line tenderness positive or negative. Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS by Rome III, of no IBS by Rome III, and of MUPS. The change of symptoms of IBS and MUPS by shigyakusan was showed with an arrow by self-declaration. Conclusions: Shigyakusan was more effective for IBS than previous medicines. IBS was diagnosed by Rome III and N line tenderness and author confirmed the existence of mild IBS which was diagnosed by N line tenderness with help of RomeIII. MUPS showed N line tenderness though patients complained of no abdominal symptoms. Shigyakusan was very effective for IBS, mild IBS and MUPS.

GSK3179106 is a potent and relatively selective inhibitor of RET kinase which has been designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients . This is a randomized, double-blind (sponsor unblind), placebo-controlled, dose escalating, four period, single-dose crossover, first time in human study to assess the safety, tolerability and pharmacokinetics of GSK3179106 in normal healthy subjects. The study will be composed of 2 cohorts, each having screening (21 days prior to first dose of study drug), Treatment, and follow-up periods (7-10 days after their last dose [Day 1 of dosing period 4]). The Treatment period will include 4 dosing periods. Subjects will participate in either Cohort 1 or Cohort 2. The total duration of the study for each subject will be approximately 10 weeks. A sufficient number of healthy subjects will be screened to enrol 16 subjects who complete the planned study procedures. Each dosing period will be staggered so that only 2 of the 8 subjects will be administered study drug initially. Once 24 hours (h) have elapsed, and provided there are no safety concerns, the remainder of subjects scheduled for that dosing period may be dosed. A review of safety and tolerability will occur prior to administration of the next dose level. This same procedure will be followed for each escalating dosing period. Subjects assigned to Cohort 1 will participate in 1 placebo and 3 dose escalating periods. Subjects assigned to Cohort 2 will participate in up to 4 dosing periods which include up to 2 escalating doses and placebo in Periods 1 and 2, and a pilot food effect in Periods 3 and 4. Within each cohort, subjects will return for their next scheduled dosing period approximately 14 days after administration of the study drug during the prior dosing period. Cohort 2 will proceed after completion of the treatment periods in Cohort 1. Each subject will be enrolled in only one cohort. The planned dose range is 10 milligram (mg) to 200 mg in Cohort 1. The actual doses to be administered may be adjusted based on safety, tolerability, and pharmacokinetic data at previous dose levels; these dose adjustments may involve either an increase or a decrease in the planned dose for both Cohorts 1 and 2. There are no formal hypotheses being tested in this study.

This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks) studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total based on previous protocol and this study.

The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to nutrition counselling. Further, the potential of both interventions to influence the gut microbiome will be inquired.

Two hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with 1week interval into the distal small intestine via working channel of a gastroscope, or to 90 g transplant into the coecum of the colon via working channel of a colonoscope. The patients shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal bacterial are determined by using 16S rRNA gene.

A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care.