Effect of Microbiome Modulation by Diet in Functional Constipation

Constipation - Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429333
• Other study ID #: 10840098-772.02-E.47859
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: December 27, 2021

Study information

• Verified date: June 2022
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 27, 2021
• Est. primary completion date: December 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

Other:
• Artificial 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.

Locations

Country	Name	City	State
Turkey	Medipol University Esenler Hospital	Istanbul	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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