Effect of Microbiome Modulation by Diet in Functional Constipation

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Artificial Intelligence-assisted Personalized Microbiome Modulation by Diet in Functional Constipation: a Randomized Controlled Trial

Conditions
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Constipation - Functional

Intervention / Treatment
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* Other: Artificial intelligence-assisted personalized diet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>After randomization control group was recommended to continue their regular diet with increased fluid (2 lt/day) and fiber intake (30 g/day) and received 5 mg of sodium picosulfate daily for 10 weeks. | |
| Experimental: Treatment group<br>In the study group, after fecal samples were taken, patients were recommended to continue their regular diet with increased fluid (2 lt/day) and fiber intake (30 g/day) for 4 weeks until the microbiome analysis resulted. During subsequent 6 weeks, they received the personalized microbiome modulatory diet. | Other: Artificial intelligence-assisted personalized diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three or more complete bowel movements per week at 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. | 10 weeks | 
| Improvement in Patient Assessment Constipation Quality of Life | 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. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome, Artificial intelligence, Diet, Functional bowel disorders, Brain-gut diseases