View clinical trials related to Constipation.
Filter by:Irritable bowel syndrome (IBS) is a gastrointestinal (GI) syndrome characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. The symptoms of IBS not only adversely affect a patient's health-related quality of life (QoL), but also place a significant financial burden on society due to reduced work productivity and increased use of healthcare-related resources. Patients with IBS frequently complain of abdominal bloating and increased gas production in the form of flatulence or belching. The prevalence in North America and Europe is approximately 10-15%. Irritable bowel syndrome affects all ages and genders however there is a 2:1 female predominance in North America. Irritable bowel syndrome is classified into 4 subtypes based on stool pattern: IBS with constipation (IBS-C), IBS with diarrhea, mixed IBS, and un-subtyped IBS. Irritable bowel syndrome with constipation is defined as the presence of hard or lumpy stools with ≥ 25 percent of bowel movements and loose or watery stools with < 25% of bowel movements. SYN-010 is a modified release, oral formulation of lovastatin being developed for the treatment of IBS-C. The SYN-010 program is based predominantly on research by Dr. Mark Pimentel and collaborators hypothesizing that reduction in intestinal methane (methane) production can reverse constipation and improve global symptoms in IBS-C. Methane production in humans is due to methanogenic archaea in the intestine, predominantly Methanobrevibacter smithii (M. smithii). Methane, the key product of anaerobic respiration of methanogens, had been perceived to produce no ill effects in humans aside from gaseous distention. However, several research groups worldwide have shown that a significant percentage of patients with IBS-C excrete methane, and elevated methane production by methanogens correlates with constipation and related symptoms in both IBS-C and chronic idiopathic constipation. A direct causative role for methane in IBS-C was demonstrated in a recent case report, wherein a woman undergoing fecal microbiota transplantation (FMT) for C. difficile infection unknowingly received stool containing a high concentration of methanogens. The FMT recipient rapidly developed severe symptoms of IBS-C that were subsequently reversed by ablation of methane production.
The research is a collaborative project by HKU and Yan Chai Hospital, funded by Social Welfare Development Fund of HKSAR. The study is designed as a prospective randomized control trial with the primary objective to investigate the efficacy of pediatric tuina (massage) on the functional constipation of pre-school aged children. Our study is a pragmatic research comparing the pediatrictuina(massage)treatment with care as usual, with the objectives of investigating 1. if a non-invasive, easy to learn pediatrictuina (massage) protocol could improve the constipation and related symptoms experienced by the pre-school age children 2. if there is a positive impact on the caregiver-children relationship and the children's behaviour (a sub-group analysis) when the constipation symptoms improved. The subjects of this study are pre-school age children (age 2-6) who are serviced by Yan Chai Hospital Social Service Department (YCHSS).The subjects will be openly recruited through the service units serving pre-school aged children under YCHSS. Rome IV criteria will be used to identify the children who suffer from constipation. I. Trial Design This is a multicentre, pragmatic randomized control trial (PRCT) with a prospective design Hypothesis 1: Applying regular pediatrictuina (massage) (3 times a week, for 4 weeks ) on pre-school aged children with functional constipation will improve one or more of the following symptoms. - Frequency of defecations - Episode of incontinence - Excessive stool retention - Painful or hard bowel movements - Presence of a large fecal mass in the rectum that may obstruct the toilet Hypothesis 2: The stress level of the caregiver of the study subjects improve as the constipation syndrome of the subjects improve. Hypothesis 3: The children with behavior problem who suffered from constipation will have less behavior issue when their functional constipation syndromes improved Total 160 pre-school aged children with functional constipation and their caregiver will be openly recruited from the institutions/service units operated by the pediatric service unit of Yan Chai Hospital Social Service Department.The recruited children must suffer from functional constipation symptoms (based on Rome IV criteria). All accepted subjects will be in dyad. (i.e. 1 pre-school aged child and his designated caregiver, who commits bring the child to attend all treatment and assessment sessions, respond to all caregivers' assessment and fill in the daily logbook). All applications will be screened by the social workers in the centres based on the inclusion and exclusion criteria. Qualified applicants will be invited for a health assessment conducted by registered TCM practitioner in the research team to confirm their suitability and invite them to sign the consent form. The consented dyad will be allocated randomly into treatment group and waitlist control group. II. Intervention A 10 minutes structured pediatric massage protocol with specific applications technique will be performed on the children allocated to the treatment group three times a week for 4 consecutive weeks by trained TCM practitioners in the service units of YCHSS. The caregivers of the children need to participate in all assessment sessions and fill in the log book provided. In the 1st 4 weeks, the children in the waitlist control group will not receive any pediatrictuina (massage). After the dyad completed the assessment sessions at baseline and week 4 ,(served as Treatment-as-Usual Control), children in the control group will receive the same 4 weeks of pediatric massage as the treatment group. The data collected before the treatment begins at week 4 will serve as the 2nd baseline for the waitlist control group. The treatment protocol involve 8 steps.The massage area focuses on the abdomen and lower back of the recipients. All the movements/steps selected are well established and commonly used in the TCM practices. Any movement that demand professional training or involve potential risk is excluded from the protocol. III. Measurement of efficacy Efficacy of the treatments will be measured in multi dimensions before and after the treatment for both groups. The main outcome measures are defecation frequency per week, fecal incontinence frequency per week, and overall treatment success after 4 weeks intervention, 8 weeks intervention and 12 weeks (4 weeks after intervention stopped) Secondary outcome measures included - abdominal pain and painful defecation based on bowel diary, - the children's subjective level of pain during bowel movement, - score of child behavior questionnaire and - score of caregiver impact and burden
The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.
The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects with functional constipation.
Consecutive patients with Irritable Bowel Syndrome with Constipation (IBS-C) will be recruited from the outpatient clinics of the University of Michigan Health System. Eligible patients will be asked to participate in a study that will test the efficacy the PEG 3350 + a diet low in fermentable oligo, di, monosaccharides, and polyols (FODMAP) vs. PEG 3350 plus sham diet. Blinding dietary advice trials is challenging and therefore the sham diet was based on the criteria set forth by Staudacher et al. which emphasizes that the diet must give the impression that is the true intervention diet with similar restrictions, modifications, and time intensity without impacting the intake of essential nutrients, fiber, and FODMAPs. An example of the sham diet's carbohydrates includes: apples, bananas, and pears, and wheat. Oranges, raspberries, strawberries and rice would not be allowed. Additionally, the physicians analyzing the data will be blinded as to which group the patients were randomized.
Prospective, randomised, double-blind, double-dummy, placebo-controlled, parallel-group, multi-centre, phase III trial of Naloxone HCl PR Tablets (12 mg and 24 mg) administered twice daily. The trial will consist of four phases: Screening phase (Week -4 to Week -3): Confirmation phase (Week -2 to Week -1): Double-blind treatment phase Follow-up phase (Week 13-14):
The objective of the study is to investigate whether lactulose, given orally as powder or liquid, increases blood glucose levels in patients with diabetes mellitus type 2. The dose of lactulose given in the study is normally used for treatment of constipation.
Children with functional constipation according to the Rome IV criteria will be randomly assigned to receive prunes at dose 3.5 g/kg/d (prune group) or Polyethylene Glycol 4000 (PEG group) at dose 0.5 g/kg/d for 4 weeks. Before treatment children with impaction will receive PEG 4000 at the dose 1.5 g/kg for 3-5 consecutive days. The primary outcome measure will be treatment success, defined as ≥3 BM per week with no fecal soiling during last week of the intervention.
This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.
A significant group of children with functional constipation (FC) continues to have symptoms despite recommended standard therapy. Underlying psychiatric problems could explain therapy resistance. However, a work-up for psychiatric problems is only recommended after unsuccessful 6 months standard therapy. Earlier detection and check-up could lead to faster start-up of a more adequate therapy. Therefore, we investigate the prevalence of emotional, behavioural and social problems in the FC-population at the first contact with a paediatric gastroenterologist in a tertiary care hospital.