Active clinical trials for "Constipation"

This randomized, double-blind, controlled clinical trial among healthy volunteers with infrequent bowel movements but not severe constipation evaluate the effects of a supplementation in "symbiotic" on intestinal transit of subjects with few bowel movements per week with a verum group treated with a dietary supplement composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet and a placebo group treated with a comparative product hat looked strictly identical to the verum and contained only excipients (60% maltodextrin / 40% sucrose). The claim investigated corresponds to the section of the new EFSA (European Food Safety Authority) guidance of 2016 entitled "Claims on maintenance of normal defecation".

Rationale: constipation-related complaints are prevalent in 5-20% of the population. Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool weight, stool frequency and improvement of stool consistency. Currently, very few adults meet the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary advice may be the solution to increase dietary fiber intake and reduce constipation-related complaints in large populations. Objective: To investigate the effectiveness of personalized dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber intake in people with constipation-related complaints. Study design: This study has a one-group pre-test post-test design with a run-in period. The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week intervention period. All subjects receive the PDA. Study population: adult subjects with constipation-related complaints, defined as predominant Bristol stool form between 1-4 and not satisfied with their bowel habits (scale ranging from 1-10, cut-off <6). Possibly stool frequency ≤4 stools per week will be included as a definition. Subjects need to have a relatively low dietary fiber intake defined as <26 grams (females) or <33 grams (males), which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice based on their habitual food pattern (as assessed using a food frequency questionnaire) and preferences. Based on a special algorithm, the PDA provides high fiber alternatives for low-fiber products that subjects currently use, close to their current eating behavior, to help increase dietary fiber intake. This PDA will be provided using an online web-portal. Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal complaints and constipation quality of life and severity. Secondary parameters include dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.

Constipation consists of bowel symptoms characterized by difficulty or infrequency passage of stool, stiff stool, or a feeling of incomplete evacuation. However, its impact goes far beyond this definition. Constipation negatively impacts the quality of life (QoL) of children and adults suffering from this condition, affecting mental and physical-related QoL. Additionally, a negative impact of constipation on QoL was found in parents carrying children with constipation, affecting family functioning. People with an intellectual disability present a constipation rate of over 33%. Rett syndrome (RTT) is a complex neurodevelopmental disorder affecting about 1/10,000 females and a few males worldwide. Chronic constipation is persistent in people with RTT, with a reported prevalence higher than 74%. Specific recommendations for constipation management in RTT were developed, including behavioral, pharmacological, and surgical considerations. Recently, the literature has been enriched with papers describing the osteopathic treatment efficacy in reducing constipation. Emerging literature reported the efficacy of OMT in reducing constipation symptoms and improving QoL in typically developed people, as well as in children with disability. The present study aims to evaluate the efficacy of a specific OMT for managing chronic constipation in people with RTT and its impact on primary caregivers' quality of life. Research questions: Can an OMT improve the constipation of people with RTT, increasing the frequency of bowel movements? Can the effects of an OMT aimed at reducing the constipation symptoms in people with RTT positively impact the participants' parents' constipation-related QoL? Twelve individuals with RTT and their families will be recruited to participate in this single-blind parallel group-randomized study. Participants will be randomly divided into an experimental group (EG) and a control group (CG). After the preliminary evaluations, each participant will undergo eight OMT carried out weekly for eight weeks. The OMT will aim to facilitate bowel movements by increasing blood flow through the abdomen. At the end of the treatment, the participants will repeat the evaluation conducted before the OMT, and the collected data will be analyzed.

Post-operative constipation is one of the most common complaints after pelvic organ prolapse surgery. Psyillum fiber is an FDA-approved, over the counter dietary supplement that is commonly used to treat constipation. The investigators are conducting this study to determine if participants who receive psyllium fiber before surgery have less difficulty with their first bowel movement after surgery.

Background: Postpartum constipation is a common problem affecting postpartum mothers. Aim: To determine whether Whole Body Vibration is effective in treatment of postnatal women constipation. Design: The study was designed as a prospective, randomized, single-blind, pre-post-test, controlled trial. HYPOTHESES: It will be hypothesized that: It was hypothesized that whole-body vibration has no or limited effect in treatment of postnatal constipation RESEARCH QUESTION: Does whole-body vibration has an effect in treatment of postnatal constipation?

Test the Efficacy of Home Biofeedback Training: Currently, biofeedback requires a skilled therapist and sophisticated equipment and is not widely available. The investigators designed and tested a novel home biofeedback device and predict that home training will be as effective as office biofeedback therapy. Our specific aims are to perform a randomized controlled trial of 100 subjects with dyssynergic defecation to investigate: (A) Whether a self-administered, home-biofeedback training program with a new portable device is as effective as office-based biofeedback therapy in improving i) physiology- dyssynergia (defecation index), and ability to expel simulated stool, and ii) symptomatology- satisfaction with bowel function, number of complete spontaneous bowel movements, stool consistency, straining and quality of life. (B) Whether home-training is more cost-effective than office-based biofeedback training.

The probiotic for oral use, Probiatop®, consists of Lactobacillus acidophilus NCFM, Lactobacillus rhamnosus HN001, Lactobacillus paracasei LPC-37 and Bifidobacterium lactis HN019. Its activity will be compared with placebo (Maltodextrin). The metagenomics data will be correlated with the Quality of Life Questionnaire answers obtained from participants with intestinal transit problem. The Increase in the number of evacuations, as well as the improvement of complaints related to intestinal transit alteration will be evaluated during the study. The participants will use probiotic or placebo for a period of 28 days and the gastrointestinal function questionnaire and collect stool will be performed before the study and after period of treatment

To compare the differences of fecal microflora between constipated and non-constipated healthy children, and evaluate the efficacy of probiotics in reducing symptoms of constipation and the influence of intestinal microflora in children with functional constipation.

This research study was being done to study the effect of codeine and Naloxegol for 3 days compared to placebo on the movement of food through the colon of healthy individuals. Codeine is a commonly used pain-relieving drug that often causes constipation as an unwanted side effect. Naloxegol is a medication recently approved by the FDA for treatment of constipation induced by Codeine. The hypothesis for this study was that Naloxegol reduces the retardation of small bowel and colonic transit induced by codeine in healthy participants.

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