Effect of Microbiome Modulation by Diet in Functional Constipation

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.

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Key information

Conditions

Constipation - Functional

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medipol University Esenler Hospital

Istanbul, Other (Non U.s.), 34230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Artificial intelligence-assisted personalized diet

Other

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.

Primary outcomes

Three or more complete bowel movements per week at 10 weeks

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jun 23, 2022
Registry last updated: Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed