Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
Irritable Bowel SyndromeThe primary objective of this trial is to compare the dose-ranging pharmacodynamic effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on gastrointestinal transit in patients with C-IBS. The secondary objectives of this trial are: To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on time to first bowel movement after first drug intake. To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100 Acetate once daily on stool frequency, stool consistency, ease of passage and sensation of incomplete evacuation during the Treatment Period relative to Baseline.
Acupuncture for Irritable Bowel Syndrome
Irritable Bowel SyndromeLittle is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed. This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.
Genetic Carbohydrate Maldigestion as a Model to Study Food Hypersensitivity
Irritable Bowel Syndrome (IBS)Sucrase Isomaltase DeficiencyIrritable bowel syndrome (IBS) affects one in seven people with gastrointestinal (GI) symptoms. IBS strongly impacts quality of life, is a leading cause of work absenteeism, and consumes 0.5% of the healthcare annual budget. It manifests in women more than men with symptoms including abdominal pain, bloating, constipation (IBS-C), diarrhoea (IBS-D), and mixed presentations (IBS-M) (1). The development of therapeutic options is hampered by the poor understanding of the underlying cause of symptoms. Many patients find that certain foods (particularly carbohydrates) trigger their symptoms, and avoiding such foods has been shown effective in IBS, like in the low-FODMAP (fermentable oligo-, di-, mono-saccharides and polyols) exclusion diet. This has suggested that the food-symptom relation may involve malabsorption of carbohydrates due to inefficient digestion. However only a percentage of patients respond to this diet. Recently it has been reported that a subset of IBS carries hypomorphic (defective) gene variant of the sucrase isomaltase (SI), the enzyme that normally digests carbohydrates, sucrose and starch. This carbohydrate maldigestion (the breakdown of complex carbohydrates by a person's small bowel enzymes) is characterized by diarrhoea, abdominal pain and bloating, which are also features of IBS. This possibly occurs via accumulation of undigested carbohydrates in the large bowel, where they cause symptoms due to gas production following bacterial fermentation. Similar mechanisms may be acting at the level of other enzymes involved in the digestion, breakdown and absorption of carbohydrates (carb digestion genes -CDGs). Aim of the study is to study the prevalence of this genetic alteration in a large number of IBS patients as compared to asymptomatic controls.
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients
IBS - Irritable Bowel SyndromeDiarrheaThe goal of this interventional clinical study is to study whether the consumption of QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 - 175) will reduce the frequency of Diarrhea. 140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants will consume assigned products once a day after meals and record the critical data such as photo of feces. Three site visits will be arranged and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis. Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.
Pre-analytical Influences on a Blood Test Study
IBS - Irritable Bowel SyndromeChronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. The aim of the study is therefore to investigate whether a simple laboratory test, that can be done on a single blood sample, would be appropriate instead. This laboratory test is called 7aC4. In order to determine whether 7aC4 could be a good test for BAD, it needs to be determined whether eating a meal can alter the levels of 7aC4. The aim of this study is to measure 7aC4 at several time points before and after eating a meal, to see what effect this has on 7aC4 levels.
MHNA-001 for Young Adults With IBS
Irritable Bowel SyndromeThe main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ IBS together with care as usual in approximately 100 young adults with Irritable Bowel Syndrome.
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP)...
Irritable Bowel SyndromeTo evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University
Heart Rate Variability in Patients With Irritable Bowel Syndrome Before and After Gut-directed Hypnotherapy...
Irritable Bowel SyndromeDysregulation of the brain-gut-axis is believed to underlie symptom generation in irritable bowel syndrome (IBS). The Autonomous Nervous System (ANS) is an important route of brain-gut communication and aberrant ANS functioning, reflected in abnormalities in Heart Rate Variability (HRV) have been described in IBS. Gut-directed hypnotherapy (GHT) leads to symptom reductions in IBS and is supposed to increase parasympathetic regulation. To date, however, the role of therapeutic modulation of the ANS through GHT has been rarely examined. Aim of this pilot study is therefore to assess the impact of GHT on ANS functioning as reflected in heart rate variability. 24h-electrocardiogram before and after 10 sessions of gut-directed hypnotherapy will be administered in groups. Time and Frequency measures of Heart Rate Variability (HRV) will be extracted from 24h-electrocardiogram protocols as indicators of ANS regulation. Validated questionnaires will be utilized to assess IBS symptoms (IBS-SSS) and psychological distress (HADS-D).
Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)...
Irritable Bowel Syndrome With DiarrheaBackground: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii (Lactobacillus LB) has proven to be effective and safe for the treatment of acute diarrhea in children. Also, a clinical trial in adult patients with chronic diarrhea, showed a reduction in the number of daily stools. However, the evidence is not enough regarding the efficacy and safety of Lactobacillus LB for treatment of patients with irritable bowel syndrome with predominance of diarrhea (IBS-D). Justification for this study: Lactobacillus LB could be a promising treatment for patients with IBS-D; nevertheless, the scientific evidence in this context is limited and it is not recent. Therefore, is necessary to explore the efficacy and safety of Lactobacillus LB in patients with IBS-D according to Rome IV criteria. Hypothesis: Lactobacillus LB is useful to decrease the frequency and improve the stools consistency of patients diagnosed with IBS-D by Rome IV criteria. Primary Outcome: To compare the treatment with Lactobacillus LB at two different doses: a) 20,000 million / day, vs. b) 10,000 million / day; and to determine if one of them is better than c) placebo, to decrease the frequency (weekly average of the number of stools/day) in patients diagnosed with IBS-D by Rome IV criteria. Design of the study: Clinical trial, randomized, double-blind, placebo-controlled. Keywords: irritable bowel syndrome with diarrhea, Lactobacillus LB, treatment, efficacy, safety.
Treatment of Functional Abdominal Distension
Irritable Bowel SyndromeDyspepsiaBackground. Abdominal distention is produced by an abnormal somatic postural tone. We developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. In a randomized, placebo-controlled trial we demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a simplified biofeedback technique for the treatment of abdominal distension. Selection criteria. Visible abdominal distension after meal ingestion; patients are able to identify the offending meal. Intervention. Patients will be randomized into biofeedback in placebo groups.Three sessions of either biofeedback or placebo intervention will be performed 30 min after ingestion of the offending meal during the first 3 weeks of the intervention period. Biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth); patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: abdominal and thoracic perimeter will be recorded but not shown to the patient and a pill of placebo containing 0.5 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period. Primary Outcome Measure: Effect of the probe meal on the activity of thoraco-abdominal muscles (intercostals, external oblique, internal oblique, upper rectus, lower rectus) measured by electromyography before and after the probe meal. The response to the probe meal will be measured before and after treatment. Secondary Outcome Measures: Effect of the probe meal on sensation of abdominal distension measured by 0-6 scales after the probe meal. Changes in girth produced by the probe meal measured using a non-stretch belt placed over the umbilicus before and after the probe meal. Sensation of abdominal distension measured by 0-6 scales after each meal (breakfast, lunch, dinner) over a 7-day clinical evaluation period before and during the 4th week of the intervention.