Effect of Microbiome Modulation by Diet in Functional Constipation

Medipol Health Group

Status: Completed

Conditions: Constipation - Functional

Treatments: Other: Artificial intelligence-assisted personalized diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05429333

10840098-772.02-E.47859

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Treatment group

Experimental group

Description:

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.

Treatment:

Other: Artificial intelligence-assisted personalized diet