Constipation - Functional
Conditions
Keywords
Microbiome, Artificial intelligence, Diet, Functional bowel disorders, Brain-gut diseases
Brief summary
Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. patients fulfilling Rome IV criteria for functional constipation were randomized into two groups. The Control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.
Interventions
OTHERArtificial intelligence-assisted personalized diet
The AI-based nutritional recommendations system is based on the eating rates of the individual in a certain period, to ensure the homeostasis of the microbiome and increase the microbial diversity. After the microbiome analysis reports of the study group are released, a 6-week diet was designed regarding AI-based food scores specific to constipated individuals in accordance with the individual's lifestyle and comorbidities. Diet lists are updated according to the individual's feedback, recovery level, and wishes with weekly meetings.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients fulfilling Rome IV criteria for functional constipation (FC) * Patients who had a colonoscopy performed within the last 5 years * Patients who had a colonic transit time assessment within the last 3 months * Patients who had a magnetic resonance defecography within the last 3 months
Exclusion criteria
* Use of antibiotics, probiotics, and/or prebiotics within the last 4 weeks * Gastrointestinal endoscopy within the last 4 weeks * Major gastrointestinal surgery (total/segmental gastrectomy, small bowel and/or colonic resection) * Cholecystectomy * Inflammatory bowel diseases * Celiac disease * Any etiology of chronic constipation other than FC (irritable bowel syndrome, rectocele, dyssynergic defecation, opioid use) * Endocrine, metabolic or neurologic disorders causing constipation (hypothyroidism, Parkinson's disease, paraplegia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Three or more complete bowel movements per week at 10 weeks | 10 weeks | The proportion of patients with a mean of three or more complete bowel movements per week (CBMpW) at 10 weeks is compared between control and study groups. |
| Improvement in Patient Assessment Constipation Quality of Life | 10 weeks | The proportion of the patients with more than 50% improvement in total Patient Assessment Constipation Quality of Life score is compared between control and study groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed