Effect of Microbiome Modulation by Diet in Functional Constipation

• Sponsor: Istanbul Medipol University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05429333
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation - Functional	Other: Artificial intelligence-assisted personalized diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Artificial Intelligence-assisted Personalized Microbiome Modulation by Diet in Functional Constipation: a Randomized Controlled Trial
• Actual Study Start Date: Dec 14, 2020
• Actual Primary Completion Date: Dec 27, 2021
• Actual Study Completion Date: Dec 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. Three or more complete bowel movements per week at 10 weeks [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.

2. Improvement in Patient Assessment Constipation Quality of Life [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medipol University Esenler Hospital	Istanbul	Other (Non U.s.)	Turkey	34230

Sponsors and Collaborators

• Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istanbul Medipol University Hospital
• ClinicalTrials.gov Identifier: NCT05429333
• Other Study ID Numbers: 10840098-772.02-E.47859
• First Posted: Jun 23, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Istanbul Medipol University Hospital: Microbiome; Artificial intelligence; Diet; Functional bowel disorders; Brain-gut diseases
• Additional relevant MeSH terms: Constipation

Study Results

No Results Posted as of Jun 23, 2022