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Constipation - Functional clinical trials

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NCT ID: NCT06349031 Not yet recruiting - Clinical trials for Functional Constipation

Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction

Start date: April 15, 2024
Phase: Phase 4
Study type: Interventional

Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements. Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction. Present study has been planned to evaluate the efficacy & tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith. Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm. Secondary outcomes are defined as follows: 1. Total no of Days required to achieve fecal disimpaction in each arm 2. Cumulative dose of PEG required for fecal disimpaction in each arm 3. Proportion of subjects (> 5 years age) reporting palatability issues in each arm 4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm

NCT ID: NCT06221722 Recruiting - Clinical trials for Constipation - Functional

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Start date: November 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are: - Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients - Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation. Participants will receive: - Standard physiological and psychological assessments of constipation - BOLD-fMRI tests - Standard protocol and fluoxetine treatment If there is a comparison group: Researchers will compare: Refractory group/Fluoxetine sensitive group to see the specific brain alterations.

NCT ID: NCT06215924 Not yet recruiting - Clinical trials for Pelvic Floor Disorders

The Effects of Postisometric Relaxation Technique in Female Patients With Dyssynergic Defecation

Start date: January 15, 2024
Phase: N/A
Study type: Interventional

Functional bowel diseases are defined as chronic disorders of the gastrointestinal tract characterized by abdominal pain, bloating, tension and/or defecation abnormalities. Functional bowel diseases are studied under five headings: functional constipation, functional diarrhea, functional abdominal bloating / tightness and unclassifiable functional bowel disorders. Functional constipation is divided into three categories as normal transition-time constipation, slow transition-time constipation and defecation disorders. Defecation disorders occur due to improper use of pelvic floor muscles and anorectal muscles or anatomical abnormalities and account for 1/3 of all constipation. Defecation disorders characterized by excessive straining, incomplete defecation sensation, difficult and painful defecation are defined as narrowing of the fecal exit path due to involuntary pelvic floor contractions or posterior compartment pelvic organ prolapse. Non-pharmacological treatment in the treatment of functional constipation is considered as the first-line treatment and includes information about the nutrition, fiber-liquid consumption, physical activity and toilet training of patients. Biofeedback therapy is often recommended in patients with defecation disorders in the literature, and there are studies showing that it is superior to laxative use and placebo applications in the studies conducted. However, the fact that it is difficult and costly to achieve Biofeedback treatment, the method used allows movement at a certain angle and does not include the stretching method seems to be a disadvantage. Postisometric Relaxation technique is used in cases of pain, muscle spasm and movement limitations. People with defecation disorders experience spasms, pain and movement limitations in the pelvic floor muscles. For this reason, the investigators think that the Postisometric Relaxation technique may be effective in patients with defecation disorders, and it will also provide advantages due to the fact that the method is easily accessible, does not require extra materials and devices, and has a stretching effect. The aim of this study is to investigate the effect of Postisometric Relaxation technique on constipation severity, quality of life, anal pain, muscle function and sexual function in patients with defecation disorder.

NCT ID: NCT06122558 Recruiting - Clinical trials for Constipation - Functional

Efficacy of Probiotic Against Functional Constipation

Start date: October 27, 2023
Phase: Phase 2
Study type: Interventional

This project aims to study the benefits of probiotic in modulating gut microbiota and treating functional constipation in patients aged 18-81.

NCT ID: NCT06100055 Not yet recruiting - Constipation Clinical Trials

The ReVo Study: Low-volume vs High-volume Rectal Irrigation

ReVo
Start date: March 2024
Phase: N/A
Study type: Interventional

Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support. Two systems of rectal irrigation are available based on volume delivered, low and high volume. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology. Therefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum. This trial/research aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum. The main questions it aims to answer are: - if one type of rectal irrigation is superior to the other - whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound - assess the acceptability and response rates to rectal irrigation. Participants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day. Participants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.

NCT ID: NCT06031025 Recruiting - Diarrhea Clinical Trials

Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.

FUSID
Start date: May 20, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are: - evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life - describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.

NCT ID: NCT05823259 Recruiting - Constipation Clinical Trials

The Impact of Respiratory Muscle Training and Patient Education on Chronic Constipation Outcomes

Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The primary aim of this study will be to determine if a respiratory muscle training program that includes both inspiratory muscle training (IMT) and expiratory muscle training (EMT), targeted at improving respiratory muscle performance-based measures combined with patient education about breathing on the toilet will improve patient satisfaction scores in individuals with chronic constipation (CC).

NCT ID: NCT05714410 Completed - Clinical trials for Constipation - Functional

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG Compared to Placebo

TYPHOON-02
Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults With Constipation as Compared to Placebo (Typhoon 2)

NCT ID: NCT05541991 Completed - Clinical trials for Constipation - Functional

Study on the Effect of Rhubarb Extract on Stool Frequency and Biological Markers of Intestinal Function in Seniors With Low Defecation

Start date: February 10, 2017
Phase: N/A
Study type: Interventional

Randomized double-blind clinical study versus placebo evaluating the effect of supplementation with rhubarb extract on stool frequency and biological markers of intestinal function in seniors with a low number of defecations per week

NCT ID: NCT05496543 Recruiting - Clinical trials for Constipation - Functional

Acupuncture for Functional Constipation in Older Adults

Start date: October 10, 2022
Phase: N/A
Study type: Interventional

Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".