View clinical trials related to Functional Constipation.
Filter by:The goal of this clinical trial is to learn if supplementation with prebiotics and/or probiotics can lead to an improvement in symptoms of patients with functional constipation. The main objectives are: - To evaluate the effect of the dietary supplements on the bowel frequency movements in patients with chronic functional constipation, after 8 weeks. - To evaluate the stool consistency after 8 weeks (Bristol scale). - To evaluate the quality of life scale score for patients with Constipation (CVE20 and GSRS scales), after 8 weeks. Participants are randomized into the following groups: - Group A: 20 assigned to probiotic + placebo - Group B: 20 assigned to prebiotic + placebo - Group C: 20 assigned to probiotic + prebiotic - Group D: 20 assigned to the placebo + placebo Participants took 4 units of product per day (2 of each assigned product) for 2 months.
This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups.
The aim of the study is to determine the effect of therapeutic touch on functional constipation in infants and young children.
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
In this prospective, randomized controlled study, n=140 female students with functional constipation studying at two universities Faculty of Health Sciences and meeting the Rome-IV Diagnostic Criteria for Constipation will be included in the study. Between 15.03.2024 and 31.05.2024, n=140 (35=control group, 35=kegel exercise group, 35=abdominal exercise group, 35=abdominal and kegel exercise group) volunteered to participate in the study. Female students with functional constipation will be randomly divided into four groups as intervention and control groups. Personal Information Form", "Bristol Stool Scale", "Constipation Severity Scale", and "Patient Assessment of Constipation Quality of Life Questionnaire" will be used in this study. The scales will be used in the research two times: pre and post-test (scales were reassessed at the end of the study after the exercise intervention). Descriptive statistics, Pearson, and Spearman's correlation analyses will be used in the analysis of research data.
In this study, we will evaluate the efficacy of prebiotics combined with quadruple probiotics in the treatment of functional constipation through an open RCT study. The experimental group received lifestyle guidance and combined intervention of prebiotics and quadruple probiotics at the same time. The patients took the combination of prebiotics and probiotics twice a day during the treatment period. The control group received only lifestyle instruction. At the same time, to evaluate the safety of probiotics combined with quadruple probiotics in the treatment of functional constipation, and provide a new treatment plan for clinical treatment of functional constipation.
It is a functional bowel disease characterized by excessive straining during defecation, infrequent defecation, and the feeling of incomplete evacuation. There are very few studies investigating the incidence and prevalence of functional constipation.Non-pharmacological treatment methods, including lifestyle changes, are primarily recommended for the treatment of constipation. The aim of the study is to examine the effects of visceral osteopathic approaches on individuals diagnosed with functional constipation and compare them with conventional methods.
Investigate the effect of a probiotic (live bacteria) in individuals with functional constipation.
Using a placebo as a control, this study aims to preliminarily evaluate the clinical efficacy of Congrong Runtong oral liquid for the treatment of functional constipation (Yang-deficiency type), explore the optimal dosage of Congrong Runtong oral liquid for functional constipation (Yang-deficiency type) to provide a basis for dosage selection in Phase III clinical trials, and observe the safety of clinical use of Congrong Runtong oral liquid.
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility. Currently, there are no pharmacological therapies approved for the treatment of FC. This study will assess adverse events and change in disease activity with linaclotide therapy in participants with FC. Linaclotide is an approved drug being developed for the treatment of FC in pediatric patients who meet modified Rome IV criteria for childhood FC. In Part 1 of this study, participants are placed in 3 groups, which occur consecutively. Each group receives a different dosage of linaclotide. In Part 2 of the study, participants will be randomly assigned to receive either linaclotide or placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 30 pediatric participants 6 months to less than 2 years of age with FC will be enrolled in the study at about 25 sites worldwide. Participants will receive oral solution of linaclotide prepared from capsule by parent/guardian once daily for 4 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.