Back to resultsEffect of Microbiome Modulation by Diet in Functional Constipation
Primary Purpose
Constipation - Functional
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Artificial intelligence-assisted personalized diet
Sponsored by
About this trial
This is an interventional treatment trial for Constipation - Functional focused on measuring Microbiome, Artificial intelligence, Diet, Functional bowel disorders, Brain-gut diseases
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)
Sites / Locations
- Medipol University Esenler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Treatment group
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05429333
First Posted
June 17, 2022
Last Updated
June 17, 2022
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05429333
Brief Title
Effect of Microbiome Modulation by Diet in Functional Constipation
Official Title
Effect of Artificial Intelligence-assisted Personalized Microbiome Modulation by Diet in Functional Constipation: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
December 27, 2021 (Actual)
Study Completion Date
December 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional
Keywords
Microbiome, Artificial intelligence, Diet, Functional bowel disorders, Brain-gut diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Arm Title
Treatment group
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Artificial intelligence-assisted personalized diet
Intervention Description
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 Outcome Measure Information:
Title
Three or more complete bowel movements per week at 10 weeks
Description
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.
Time Frame
10 weeks
Title
Improvement in Patient Assessment Constipation Quality of Life
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Medipol University Esenler Hospital
City
Istanbul
State/Province
Other (Non U.s.)
ZIP/Postal Code
34230
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Microbiome Modulation by Diet in Functional Constipation
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