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Constipation clinical trials

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NCT ID: NCT02884167 Completed - Constipation Clinical Trials

Multidimensional Risk Factor Assessment in Constipation

Start date: June 2016
Phase: N/A
Study type: Observational

Constipation is a symptom based disorder with a prevalence of 15% in the adult population and its management remains challenging. Although not life threatening, constipation is associated with impaired quality of life, increased healthcare costs and excess work absenteeism. Constipation represents a heterogeneous disorder with a multifactorial pathogenesis. Several risk factors have been suggested to lead to the condition and are divided in 3 main categories: a) physiological, b) environmental and c) demographic. To date, there is lack of large epidemiological studies on proposed aetiological factors of constipation, especially studies assessing all proposed risk factors of constipation together. The overall aim of this study is to investigate the multidimensional (physiological, environmental and demographic) predictors of constipation with the use of a multivariate analysis statistical model. This is a large single centre case control study comparing constipated adults with healthy individuals matched for age, gender and ethnicity. The duration of the study is 2 weeks in total and includes a screening visit, a 2 week run-in period and a baseline visit at the end of the run-in period. Transit time between constipated and healthy individuals is assessed at baseline visit. Differences in gastrointestinal symptoms, dietary intake as well as differences in stool output (e.g. stool frequency and consistency) between constipated and healthy individuals are assessed over the baseline period (the week before the baseline visit). Differences in female sex hormone levels as well as stool markers and markers of fermentation (e.g. fecal water, stool pH, short chain fatty acids) between constipated and healthy individuals are assessed at baseline visit. Furthermore, differences in environmental measures (physical activity, anxiety, smoking) and differences in demographic measures (age, gender, body mass index) between patients suffering from constipation and healthy individuals are also assessed at baseline visit.

NCT ID: NCT02867917 Completed - Constipation Clinical Trials

Comparison of Taste and Palatability in Fiber Supplements

Start date: November 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to compare 1. taste and 2. texture/palatability of Metamucil orange®, Volcolon® and generic orange psyllium.

NCT ID: NCT02863848 Completed - Constipation Clinical Trials

Effect of Inulin-type Fructans on Constipated Children.

CONSTICHILD
Start date: September 2012
Phase: N/A
Study type: Interventional

The main objective of this Pilot study was to assess the beneficial effects of a daily supplementation with Orafti inulin‐type fructans in 2‐5 year old constipated children The study is primary aimed to develop a feasibility study to assess the beneficial effect of inulin‐type fructans in the described population with regard to the adequate criteria for a larger trial. Secondary objectives are to obtain data about the feasibility of the protocol (as pilot study). To obtain data useful to perform sample size calculations for a big study designed specifically to investigate the beneficial effect of inulin‐type fructans in the treatment of constipated children. Study design and subjects: Double‐blind, randomized, placebo‐controlled parallel group trial; where 2‐5 year‐old constipated children received inulin‐type fructans or the same amount of placebo (maltodextrin) during 6 weeks. The study protocol was approved by the local Ethical Committees. Outcomes: primary outcome was stool consistency. Secondary outcomes were: stool frequency, gastrointestinal symptoms (abdominal pain and pain during defecation), additional medication required (yes/no), and colonic transit time. Stool samples at baseline, end of intervention and after follow‐up were obtained in order to be analysed to know about the microbiota. Dietary intake was also recorded at baseline, end of intervention and after follow-up. Principal subject inclusion criteria: Subjects were recruited if fulfil the Rome III constipation criteria (Mainly hard stools plus stool retention, or pain, or low frequency). Principal subject exclusion criteria: Age under 2 or over 5 years, diapers use, use of laxative during the study and 2 weeks before, use of pre‐ probiotics or antibiotics during the study and 4 weeks before, organic causes of defecation disorders, other metabolic or renal abnormalities or mental retardation, no parent's command of any local language.

NCT ID: NCT02844426 Completed - Clinical trials for Slow Transit Constipation

Effect of a Synbiotic on Symptoms of Patients With STC

Start date: September 2015
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.

NCT ID: NCT02838797 Completed - Parkinson's Disease Clinical Trials

RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease

RQ-10
Start date: June 2016
Phase: Phase 1
Study type: Interventional

This is a study to determine the safety and tolerability of a new medicine (RQ10) for gastrointestinal symptoms in Parkinson's disease. The investigators will also begin to look at the effect of this medicine on gastrointestinal problems. The results will determine if future studies are appropriate. In this study, RQ10 will be compared to a placebo (a look-alike inactive substance). Participation will include multiple office visits. Approximately 48 people will participate.

NCT ID: NCT02836717 Completed - Constipation Clinical Trials

Long Term Efficacy of Sacral Nerve Modulation (SNM) in Patients With Constipation or Stool Incontinence

Start date: April 2016
Phase:
Study type: Observational

The aim of this study is to determine the success rate, the success duration, the complication rate, maintenance effort and quality of life several years after sacral nerve modulation (SNM) treatment for constipation or stool incontinence.

NCT ID: NCT02822508 Completed - Constipation Clinical Trials

A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

Start date: June 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and efficacy versus placebo in adults experiencing non-idiopathic constipation.

NCT ID: NCT02820714 Completed - Constipation Clinical Trials

A Pilot Study of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate BLI801 laxative in adults experiencing non-idiopathic constipation.

NCT ID: NCT02819310 Completed - Constipation Clinical Trials

An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults

Start date: June 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety of chronic use of BLI400 laxative in constipated adults.

NCT ID: NCT02819297 Completed - Constipation Clinical Trials

BLI400-302: A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Start date: June 2016
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate a daily dose of BLI400 Laxative for safety and efficacy versus placebo in constipated adults.