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Constipation clinical trials

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NCT ID: NCT01212146 Completed - Clinical trials for Functional Constipation

Probiotic-enriched Artichoke in Functional Constipation

PAFC
Start date: September 2010
Phase: N/A
Study type: Interventional

The aim of the present randomized double-blind controlled crossover study is to compare the effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients suffering from functional constipation.

NCT ID: NCT01210625 No longer available - Constipation Clinical Trials

Starch-entrapped Microspheres [Nutrabiotix Fiber] for Gut Health

NTX
Start date: n/a
Phase:
Study type: Expanded Access

The investigators hypothesize that daily oral intake of starch-entrapped alginate microspheres (called Nutrabiotix fiber) is well tolerated, exhibits no or minimal "typical" side effects of fiber (e.g. bloating, loose stool, flatulence), can be used as an ideal vehicle to deliver anti-oxidants/anti-inflammatory natural and synthetic substances/agents; and promote gut health by improving bowel habit, by changing the gut microbiota and increasing production of short chain fatty acids, especially butyrate, in the colon and decreasing production of protein putrification (prebiotic effects).

NCT ID: NCT01207427 Completed - Clinical trials for Opioid Induced Constipation

Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain

Start date: October 14, 2010
Phase: Phase 2
Study type: Interventional

Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI tract. The most common symptoms associated with the effects of opioids are constipation and nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of long-term opioid therapy. The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo in the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy for chronic noncancer pain.

NCT ID: NCT01190020 Completed - Clinical trials for Chronic Constipation, Methanogenesis

Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.

Start date: February 2009
Phase: Phase 1
Study type: Interventional

Lubiprostone, a chloride channel activator, has been shown to improve symptoms of chronic constipation, largely by enhancing chloride-rich intestinal fluid secretion. Whether Lubiprostone has effects on colonic methanogenesis is not known. The investigators hypothesize that the effects of Lubiprostone may in part be due to its effects on altering colonic flora, particularly methanogenic flora. By altering the colonic stasis of stool and through more efficient clearance of digestive residue, the investigators anticipate that Lubiprostone may either inhibit or promote better excretion of methanogenic flora, and thereby decrease the gut load of methane producing bacteria. In turn, this may lead to enhanced colonic smooth muscle contraction and an increased rate of spontaneous bowel movements and reduction of constipation symptoms. The aim is to investigate the effects of Lubiprostone on intestinal methane production and bowel symptoms in patients with chronic constipation, by performing a randomized, double blind, placebo controlled study.

NCT ID: NCT01189409 Terminated - Cancer Clinical Trials

Polyethylene Glycol (PEG) Versus Sennosides Study in Opioid-Induced Constipation in Cancer Patients

Start date: June 2010
Phase: Phase 4
Study type: Interventional

This is a study to compare the efficacy and tolerability of two laxatives for treatment of opioid-induced constipation in adult outpatients with cancer treated at the British Columbia Cancer Pain and Symptom Management/Palliative Care clinics. Each participating patient will be randomly assigned to one of two treatment groups.

NCT ID: NCT01186770 Completed - Clinical trials for Opioid-Induced Constipation

A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain

Start date: September 1, 2010
Phase: Phase 3
Study type: Interventional

MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

NCT ID: NCT01185431 Completed - Clinical trials for Functional Constipation

The Effects of a Ficus Carica on Improvement in Bowl Movements in Female Volunteer With Functional Constipation

Start date: July 2010
Phase: N/A
Study type: Interventional

This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation: To evaluate the improvement of the bowel To assess the quality of life and impact on female reproductive function To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol

NCT ID: NCT01180725 Completed - Constipation Clinical Trials

Investigation of Dried Plums in the Treatment of Adults With Constipation

Start date: n/a
Phase: Phase 4
Study type: Interventional

Background: Constipation is a common problem that affects nearly 60 million Americans. The treatment of constipation remains challenging with one half of patients dissatisfied with current therapy. There is a need for a food-based, natural, convenient and tasty alternative to the currently available OTC laxatives and fiber supplements, particularly for patients with occasional and mild constipation. Dried plums and prune juice have been traditionally used for the treatment of constipation but has not been systematically assessed in patients with well defined constipation. Also, the efficacy, palatability and tolerability of dried plums in the treatment of chronic constipation have not been examined. Aim: To investigate and compare the effects of dried plums and psyllium on the overall relief of constipation symptoms, taste and quality of life in adults with functional constipation in a randomized crossover controlled trial. Methods: We propose to study 40 subjects with functional constipation in a single blinded, randomized, cross-over study comparing 3 weeks of dried plums with 3 weeks of treatment with Psyllium Data analysis: The primary outcome measure will be the global relief of constipation symptoms as rated by the subject at the end of each phase of the study. Additionally, we will assess several secondary outcome measures that will include the number of Complete Spontaneous Bowel Movements (CSBM) per week, Quality of Life , psychological profile, patient rating of taste on a VAS scale, patient rating of bloating, distension, satiety and fullness and patient rating of constipation-related symptoms. Expected Results: We anticipate that treatment with dried plums will improve symptoms of constipation compared to the baseline. This improvement will be comparable to that achieved with psyllium (Metamucil) treatment. Additionally, dried plums will offer a natural, food based, convenient and more tasty alternative to over-the-counter laxatives and fiber supplements.

NCT ID: NCT01170039 Completed - Diabetes Clinical Trials

The Effectiveness of Lubiprostone in Constipated Diabetics

Start date: September 2010
Phase: Phase 4
Study type: Interventional

The investigators will recruit a total of 136 diabetic men and women with constipation into this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours after initiation of study drug (SBMs) in all patients two weeks before treatment with lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule. Colon transit reflects that rate of colonic peristalsis and movement of stool through the large bowel. Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will over-sample African American patients to achieve approximately 50% enrollment of this group. In a subanalysis, the investigators will assess response to treatment between the general population and African Americans. We hypothesize that lubiprostone will significantly increase the number of SBMs as well as decrease colonic transit time and improve quality of life in constipated diabetic patients compared with placebo.

NCT ID: NCT01162863 Completed - Clinical trials for Irritable Bowel Syndrome

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation

Start date: November 2010
Phase: N/A
Study type: Interventional

Irritable bowel syndrome (IBS) is a common disorder which presents with abdominal pain or discomfort in association with altered bowel habit. IBS is further subcategorized as three types according to the predominant bowel movement pattern: IBS with constipation (IBS-C), IBS with diarrhea (IBS-D), and mixed-IBS (IBS-M). The exact causes of IBS remain incompletely understood, but proposed mechanisms include abnormal motility, visceral hypersensitivity, abnormal brain-gut interactions, psychological distress, and altered GI tract motility. Lubiprostone, a novel drug that works by activating the colonic ClC-2 chloride channel, has been approved for use in patients with chronic idiopathic constipation and recently approved for the treatment of IBS-C in women aged 18 and older. By activating the ClC-2 chloride channel in the colon, lubiprostone allows more fluid secretion into the intestinal lumen which leads to softer stool consistency. In phase III clinical trials, patients with IBS-C receiving lubiprostone have reported improvements in many symptoms such as abdominal pain and constipation. However, there is limited physiologic data to explain how exactly lubiprostone improves IBS-C symptoms. The Smartpill is a novel non-digestible capsule that is capable of measuring intraluminal pH, pressure, and temperature in the gastrointestinal (GI) tract. Smartpill has been shown to accurately measure whole gut as well as regional (i.e. stomach, small bowel, colon) transit time. The primary aim of this study is to determine the effects of lubiprostone on whole GI tract transit, colonic transit, motility, and intraluminal pH in patients with IBS-C through evaluation with the Smartpill. The investigators propose to study the effect of lubiprostone vs. placebo on these parameters, and secondarily to evaluate changes in these parameters with differing doses of lubiprostone. The investigators hypothesize that lubiprostone will increase whole GI and colonic transit compared to placebo in patient with IBS. the investigators do not expect a change in intraluminal pH with lubiprostone compared to placebo.