Effect of Microbiome Modulation by Diet in Functional Constipation

NCT ID: NCT05429333

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2021-12-27

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.

Conditions

Constipation - Functional

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment group

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.

Group Type: EXPERIMENTAL

Artificial intelligence-assisted personalized diet

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medipol University Esenler Hospital

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

Countries

Turkey (Türkiye)

Other Identifiers

10840098-772.02-E.47859

Identifier Type: -

Identifier Source: org_study_id