The Effect of AI-based Microbiome Diet on IBS-M Symptoms
Primary Purpose
Irritable Bowel Syndrome Mixed
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Personalized microbiome diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome Mixed
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with IBS by a medical doctor.
- BMI between 18.5-39.9 kg/m2
- No hospitalization in the last 12 months.
- No antibiotics use in the last 6 months.
- No cancer diagnosis by a medical doctor.
- No chronic complex diseases including diabetes and hypertension.
Exclusion Criteria:
- Not being diagnosed with IBS.
- Having a diagnosed chronic disease.
- Having a diagnosed mental or psychiatric disorder .
- Having endocrinal disorders.
- Being pregnant.
- Antibiotics use in the last 6 months.
- Hospitalization history in the last 12 months.
- Drug use.
- Being morbid obese.
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Personalized microbiome diet
Standard IBS diet
Arm Description
Six weeks of AI-based microbiome diet was introduced.
Six weeks of standard IBS diet was introduced.
Outcomes
Primary Outcome Measures
IBS-SSS change
Change in IBS-SSS scores according to ROME IV criteria were assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT04768387
First Posted
February 19, 2021
Last Updated
February 22, 2021
Sponsor
Gazi University
Collaborators
Enbiosis Biotechnology, TC Erciyes University
1. Study Identification
Unique Protocol Identification Number
NCT04768387
Brief Title
The Effect of AI-based Microbiome Diet on IBS-M Symptoms
Official Title
An Open-labelled Interventional Study With 25 IBS-M Patients in Which Group 1 (n=14) Followed Six Weeks of AI-based Microbiome Diet and Group 2 (n=11) Followed Standard IBS Diet
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
Collaborators
Enbiosis Biotechnology, TC Erciyes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Patients were divided into two groups based on age, gender and microbiome matched.
Six weeks of AI-based microbiome diet (n=14) for group 1 and standard IBS diet (Control group, n=11) for group 2 were followed. AI-based diet was designed based on optimizing a personalized nutritional strategy by an algorithm regarding individual gut microbiome features. An algorithm assessing an IBS index score using microbiome composition attempted to design the optimized diets based on modulating microbiome towards the healthy scores. Baseline and post-intervention IBS-SSS (symptom severity scale) scores and fecal microbiome analyses were compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome Mixed
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized microbiome diet
Arm Type
Experimental
Arm Description
Six weeks of AI-based microbiome diet was introduced.
Arm Title
Standard IBS diet
Arm Type
Active Comparator
Arm Description
Six weeks of standard IBS diet was introduced.
Intervention Type
Dietary Supplement
Intervention Name(s)
Personalized microbiome diet
Other Intervention Name(s)
ARTIFICIAL INTELLIGENCE BASED PERSONALIZED DIET
Intervention Description
The personalized nutrition model estimates the optimal micronutrient compositions for a required microbiome modulation. In this study, we computed the microbiome modulation needed for an IBS case, based on the IBS-indices generated by the machine learning models. According to that, the baseline microbiome compositions are perturbed randomly with a small probability p. Perturbed profiles are accepted with a probability proportional to the decrease in the IBS-index as suggested by Metropolis sampling. This Monte-Carlo random walk in the microbiome composition space is expected to meet a low IBS-index microbiome composition nearby the baseline microbiome composition of the patient with a minimal modulation. The personalized nutrition model, then, estimates the optimized nutritional composition needed for this individual, expecting to drive the IBS-index to lower values.
Primary Outcome Measure Information:
Title
IBS-SSS change
Description
Change in IBS-SSS scores according to ROME IV criteria were assessed.
Time Frame
Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed with IBS by a medical doctor.
BMI between 18.5-39.9 kg/m2
No hospitalization in the last 12 months.
No antibiotics use in the last 6 months.
No cancer diagnosis by a medical doctor.
No chronic complex diseases including diabetes and hypertension.
Exclusion Criteria:
Not being diagnosed with IBS.
Having a diagnosed chronic disease.
Having a diagnosed mental or psychiatric disorder .
Having endocrinal disorders.
Being pregnant.
Antibiotics use in the last 6 months.
Hospitalization history in the last 12 months.
Drug use.
Being morbid obese.
Facility Information:
Facility Name
Gazi University
City
Ankara
Country
Turkey
12. IPD Sharing Statement
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The Effect of AI-based Microbiome Diet on IBS-M Symptoms
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